Infusion pumps and sets - recalled due to pumps may not deliver fluid at the accuracy specified in the instructions, USA

3 years ago •source www.fda.gov

Recall notice

Infusion pumps and sets - recalled due to pumps may not deliver fluid at the accuracy specified in the instructions photo #1

United States

Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
FDA Recall date: April 29, 2020
Recall details: CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020). Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market.

The following is a summary of each individual product recall details:

CMEAmerica BodyGuard® Infusion Pump Recall

Details On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic: Use of products in the field in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter; Product service and repair activities at CME America and Authorized Service Depots; and Supply of infusion sets and accessories to support the infusion pumps remaining in the field.

The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
- BodyGuard 121
- BodyGuard 323
- BodyGuard 545*
- BodyGuard 575*
- BodyGuard 545 ColorVision
- BodyGuard 575 ColorVision
- CMExpress

*Note: These two pump models were inadvertently left out of the initial customer notification

CMEAmerica BodyGuard® Microset Infusion Set Recall

Details On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers. Affected products include:

CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cme-america-provides-update-two-previously-announced-voluntary-recalls-related-ambulatory-infusion

Source: FDA

#medicaldevices #us #evolve

303

Related Reports

Medline and Centurion Convenience kits - recalled due to lack of sterility, USA

1 week ago •source www.fda.gov

Recall notice

In direct response to the Nurse Assist, LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a nationwide recall on November 15, 2023, for its Medline and Centurion branded convenience kits containing Nurse Assist 0.9% Sodium … See More
Chloride Irrigation USP and Sterile Water for Irrigation USP. The Nurse Assist recall was issued due to the potential for a lack of sterility, which could result in non-sterile products. Medline Industries, LP has received one adverse event associated with product manufactured by Nurse Assist.

Water-based medical products that are non-sterile and potentially contaminated could cause serious or life-threatening infections, including bloodstream, urinary tract, open wound/soft tissue, and respiratory infections. Patients who are elderly, critically ill, have weak immune systems (including newborn infants, pregnant women, and cancer patients), or have chronic diseases are particularly at risk of infection. However, other patients could also develop infections after exposure to contaminated water-based medical products.

The recall affects Medline and Centurion convenience kits that may be used at home by patients, caregivers, and home health providers, as well as convenience kits that may be used in medical settings for surgery or other medical procedures. Recalled kits include, but are not limited to, wound care kits, tracheostomy kits and catheter kits. A detailed list of recalled Medline and Centurion convenience kits, as well as an example of product labeling, can be found in the link below.

Consumers who have recalled product should stop using the product and contact Medline immediately.

Medline Industries, LP notified its direct distributors and consumers of the Nurse Assist recall by First Class Mail and email on 11/16/23, upon receipt of initial recall notification from Nurse Assist. Customers who received the recalled product were given instructions to quarantine all affected products immediately and provide Medline with a response regarding the affected quantity on hand. Upon confirmation of the affected quantity, Medline provided customers with over-labels to place on the affected inventory, with instructions for staff to remove the affected component before using the kit. The recall notification also instructed distributors and those who resold or transferred affected product to another company or individuals to notify their customers of this recall notification.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Medline Industries, LP
Brand name: Medline and Centurion
Product recalled: Convenience kits
Reason of the recall: The potential for a lack of sterility
FDA Recall date: April 08, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-nationwide-recall-convenience-kits-containing-nurse-assist-09-sodium
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#medicaldevices #recall #us

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303

InfuTronix Nimbus Ambulatory Infusion Pump System recalled due to customer complaints, USA

3 weeks ago •source www.fda.gov

Recall notice

InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the … See More
Nimbus Infusion Pump systems dated May 2019 to August 2023.

Evaluation of complaint data has identified several potential product issues:
- Battery Power may potentially affect the performance of the pump by causing an immediate power off event.
- Upstream Occlusion, as noted by the upstream occlusion alarm, occurs when there is a block in flow of the proximal end of the administration set.
- System Errors, as noted by the System Error alarm which causes the pump to suspend the infusion.
- Drug product egress from certain administration set bonding points, which may potentially result in drug product leaking from the device.
- Flow Rate (high or low) which may potentially lead to the pump infusing an inaccurate delivery of the drug.
- Pump Housing design which may potentially result in damage over time to certain areas of the housing responsible for administration set engagement, leading to false occlusions and flow rate inaccuracies.

These product issues were identified through the InfuTronix post-market surveillance system and evaluated through the InfuTronix Corrective Action/Preventive Action (CAPA) system. InfuTronix has determined that the best corrective and preventive action to address the identified product issues and potential outcomes is a redesign of the Nimbus Infusion Pump system. The redesign of the system will allow InfuTronix to improve several aspects of the product including mechanics, electronics, software, and housing design as well as aspects of the administration set. Given the number of anticipated design improvements and the extensive requirement for design, verification, and validation, InfuTronix believes a new premarket notification(s) and clearance from FDA may be required. As such, InfuTronix is seeking to remove the system from the market while these improvements and design changes are being made and a new clearance(s) is obtained.

A health hazard evaluation (HHE) was performed by an independent physician to evaluate routine post-market complaint failure modes associated with the Nimbus family of infusion pumps. The HHE determined that the common device failure modes pose a low risk to users.

The Nimbus Infusion Pump system has been distributed throughout the United States since October 17, 2014 until February 21, 2024. It has never been distributed internationally. Affected devices have the following Unique Device Identification numbers associated with them:
- Nimbus Ambulatory Infusion Pump 00817170020000
- Nimbus II PainPRO 00817170020086
- Nimbus II Flex 00817170020093
- Nimbus II Plus 00817170020161
- Nimbus II EpiD 00817170020376
- Nimbus II EMS 00817170020109

Users may continue to use the Nimbus Infusion Pump system and associated infusion sets during this removal process. Users should be aware of the signs indicating a potential issue with the pump (How to recognize that a device may fail):

- Battery – The infusion pump will brown out (fail-safe). The user will see that the pump has shut off. Additionally, the LED screen may flicker prior to failure, indicating a potential battery issue.
- Upstream Occlusion - Auditory and visual occlusion alarm alerts the user of the occlusion.
- System Error - Auditory and visual system error alarm will alert the user.
- Drug Product Egress – The user may notice leaking drug from the pump pouch or infusion set or feel wetness from the drug product.
- Flow Rate (high/low) - Auditory and visual occlusion alarm for low flow will alert the user of occlusion. The user will notice residual volume remaining at the end of therapy. High flow rate may be associated with shortened infusion times.
- Pump Housing Damage - The user may notice broken latches, hinges, or cracks in the housing and/or user may notice that the device is difficult to assemble prior to use.

Infutronix has already notified customers with a letter that details the products impacted, reason for the voluntary removal, risk to health assessment, how to recognize the device may fail and actions to be taken by the customer/user.

The continued use of the Nimbus Infusion Pump system and associated infusion sets is safe during this removal process. Users should be aware of the signs indicating a potential issue with the pump as described above, “How to recognize that a device may fail”. As with any use, health care providers (HCPs) should read the Instructions for Use (IFU) and follow those closely to ensure proper performance of the pump with its associated accessory set. Further, HCPs should educate patients on proper use of the pump and accessories, and potential operational concerns. As a reminder to HCPs,

- When replacing batteries, only new batteries should be used. Care should be taken to ensure that old and new batteries are not confused when completing the replacement. When resetting the battery state, HCPs are encouraged to pay close attention to the device indicator lights and LED screen indicating battery life.
- HCPs should take care to clear an occlusion alarm properly. The battery should not be cycled (turned on/off) to clear the occlusion alarm. If the occlusion alarm cannot be cleared, a new pump should be used. Patients should be educated that silencing the alarm does not clear the occlusion.
- Due to the potential ambulatory use of the pump, patients may carry the drug product dispensing pouch in a carrying pack. Patients should be educated that impeding the tubing set or placing pressure on the device (leaning against it, sitting on it) may cause the device to malfunction.
- HCPs are encouraged to educate patients on potential drug leakage and establish appropriate containment protocols for users to follow.

HCPs should ensure users are educated to recognize audio and visual alarms and inspect their device for damage. Any difficulties or abnormalities noted with the pump or accessories should result in immediate discontinued use of the pump and notification to the HCP. Customers of InfuTronix who have Nimbus Infusion Pumps and associated infusion sets in their possession should contact InfuTronix customer service, where they will be instructed on the Return Material Authorization (RMA) process to be followed for returning both the Nimbus Infusion Pumps and associated infusion sets.

Customers who purchase the Nimbus Infusion Pump and/or associated infusion sets from a distributor should contact their distributor directly and receive instructions on the RMA process to be followed. As the device will not be available or supported after June 20, 2024, InfuTronix encourages the healthcare provider to seek alternative methods of drug product infusion appropriate for their patient’s needs, based on their medical expertise, at the earliest possible opportunity. InfuTronix is removing the Nimbus Infusion Pump Systems from the market.

The products will no longer be supported by InfuTronix for either Nimbus Infusion Pumps or related infusion sets beyond June 20, 2024. To return Nimbus products customers should follow the instructions provided in the Medical Device Removal letter that was sent by InfuTronix, contact InfuTronix customer service or their local distributor.

Company name: InfuTronix, LLC
Brand name: Nimbus
Product recalled: Nimbus Pump System
Reason of the recall: Recall due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump systems
FDA Recall date: March 20, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-removal-announcement-infutronix-nimbus-ambulatory-infusion-pump-system
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#medicaldevices #us

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303

Several Brand CPAP and BIPAP Masks with Magnets - recalled due to interference with medical implants, USA

4 weeks ago •source www.fda.gov

Recall notice

On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or … See More
the position of the implant, potentially resulting in serious injury or death. Sleepnet has been distributing masks with magnets worldwide since 2006 and to date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets.

Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This is applicable to all lot/UDI numbers.

Sleepnet masks with magnets are safe when used in accordance with the newly updated Instructions for Use. Continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Sleepnet is adding a new contraindication and an updated warning to the Instructions for Use labeling of the affected products. This will be included in the labeling for all future production of these masks. The labeling will be updated to state the following:
1- New Contraindication:
Do not use this mask if you or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets. Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic metallic implants/electrodes/valves placed in upper limbs , torso, or higher, etc. If you have any questions regarding the implant, consult your physician or the manufacturer of your implant.

2- Updated Warning:
Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This applies to you or anyone in close physical contact with your mask.

If a patient, or anyone in close physical contact, has an active medical implant or metallic implant, they should contact their mask supplier to find a replacement mask that does not include magnets. If the patient is unsure whether or not they should use the mask, they should consult their physician or the manufacturer of their implant.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Sleepnet Corporation
Brand name: Mojo, Mojo 2, iQ 2, Phantom 2
Product recalled: CPAP and BIPAP Masks with Magnets
Reason of the recall: Potential interference with certain medical implants
FDA Recall date: March 18, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sleepnet-corporation-issues-worldwide-recall-cpap-and-bipap-masks-magnets-due-potential-interference
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#medicaldevices #us

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303

Megadyne Electrodes - Alert to Use for ages 12+ only, USA

1 month ago •source www.fda.gov

Recall notice

Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA … See More
SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.

Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.

The list below contains the specific product and codes in scope.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode, Product Code: 0845, UDI-DI: 10614559103906.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode, Product Code: 0846, UDI-DI: 10614559104248.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode, Product Code: 0847, UDI-DI: 10614559104842.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode, Product Code: 0848, UDI-DI: 10614559104859.

Customers should review and follow the instructions provided in the December 2023 recall notification (link given below). Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.

Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Megadyne Medical Products, Inc.
Brand name: Megadyne
Product recalled: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
Reason for the recall: Limit use to patients aged 12 years or older.
FDA Recall date: February 29, 2024

Recall link of December 2023: www.jnjmedtech.com/libraries/pdf.js/web/viewer.html?file=/system/files/pdf/mega-soft-reusable-patient-return-electrode-medical-device-correction.pdf#pagemode=none
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadyne-reiterates-intended-use-population-change-megadyne-mega-soft-universal-and-universal-plus
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#medicaldevices #recall #us

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303

Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits recalled due to potential lack of sterility, USA

1 month ago •source www.fda.gov

Recall notice

Avanos Medical, Inc. voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon of the feeding tube. This recall initiated in direct response to … See More
the Nurse Assist, LLC voluntary recall of pre-filled syringes and other sterile water products which was promtpted due to concerns about the potential lack of sterility assurance. Avanos has not been directly contacted with any reported adverse events.

This deficiency may lead to non-sterile products, posing a risk of the water coming into contact with a patient’s surgical site. Any open wound exposed to non-sterile products could potentially put the patient at risk of infection. The pre-filled syringe is the only item in the Avanos feeding tube kit affected by the Nurse Assist recall.

As of Feb. 6, 2024, the FDA reported receiving adverse events associated with use of Nurse Assist products and is further evaluating this information.

Upon evaluating the impact of the Nurse Assist recall, Avanos has identified the affected MIC* Gastric – Jejunal Feeding Tube Kit product codes and lot numbers. Customers receiving the listed lots are instructed to remove all affected kits from facilities and requested to take the following actions:

- Continue normal post-op care for any newly placed MIC* GJ tube.
- Report any adverse events involving these products immediately.
- Check all storage facilities and warehouse locations for affected products and quarantine them.
- Destroy all affected lots in inventory.
- Notify other departments or customers of this recall.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Avanos Medical, Inc.
Brand name: Avanos Medical
Product recalled: MIC* Gastric-Jejunal Feeding Tube Kits
Reason of the recall: Potential Lack of Sterility Assurance
FDA Recall date: February 27, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avanos-medical-inc-announces-voluntary-recall-response-nurse-assist-llc-sterile-water-medical
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#medicaldevices #recall #us

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303

Recent Interesting Reports

ForeverMen Natural Energy Boost - recalled due to undeclared allergens, USA

1 week ago •source www.fda.gov

Recall notice

FAonline INC, is voluntarily recalling all lots within expiry of the ForeverMen capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the … See More
ForeverMen products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall. ForeverMen was distributed to consumers nationwide via the Internet. To date, Happy Together Inc. has not received any reports of adverse events related to this recall.

Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. The products affected are men with diabetes, high blood pressure, high cholesterol, or heart disease.

The product is marketed as dietary supplements for male sexual enhancement and is packaged in a blister card. 10 count box. We are notifying the public through this public announcement due to lack of ability to identify customers who may have received the product. FAonline INC. is notifying its customers that have the ForeverMen products to stop use and properly discard the product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

In case you experienced harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: FAonline Inc
Brand name: ForeverMen
Product recalled: Natural Energy Boost
Reason of the recall: Product is tainted with sildenafil and tadalafil
FDA Recall date: April 02, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/forevermen-supplements-recalled
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#recall #allergicreaction #dietarysupplements #us #allergen

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303

Pyramid Wholesale Dietary supplements for sexual enhancement - recalled due to Undeclared Sildenafil and/or Tadalafil, California, USA

3 weeks ago •source www.fda.gov

Recall notice

Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). There have been no reports of injury or illness, to date. They were sold in bulk to … See More
other distributors and retailers in California and out of state.

These products have the potential to cause severe adverse health effects due to misuse, overuse, interaction with other medications, underlying health conditions, and overall lack of oversight or consultation with medical professionals.

The products were distributed under 11 different brand names and varied in product form and size. A full list is available in the link below. Consumers should immediately discontinue use of the product.

Company name: Pyramid Wholesale
Brand name: Various
Product recalled: Dietary supplements for sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: March 20, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pyramid-wholesale-issues-recall-various-brands-products-sold-dietary-supplements-sexual-enhancement
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#drugs #supplement #california #us

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288
T

AP02 Air Purifier Scam, 192-01 Northern Boulevard, Flushing, NY, USA

3 weeks ago •reported by user-tckq7854

I ordered 2 AP02s air purifiers one their not the size that was on the advertised and did cost $116 I think they using someone else's website to sell their version

Reporting scam of the product from TECH 1 on 192-01 Little Falls Road, Cedar Grove, NJ, USA

Im in New York City, NY, USA

#onlineshopping #scam #delivery #onlinescam #newyork #us

AP02 Air Purifier Scam photo #1
1.4K
V

Same thing, Dallas, TX, USA

4 days ago •reported by user-vcjnp739

I placed a order on March 12th from the same company and got a tracking number stayed watching it as it supposedly went to each destination till it stated delivered on March 27th. But nothing came, my husband stayed my the front door all day waiting for … See More
it, for nothing to arrive. I've reached out to customer service with no success to do anything. And im out of $150 of my hard working money just gone...... I'm so upset don't know who to turn to. The website stated they were affiliated with Amazon and it was a secured site so I believed it was ok...... how can they use a logo of such magnitude and not be real???
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#onlineshopping #scam #onlinescam #delivery #dallas #texas #us

Same thing photo #1
786
B

Package whitout being ask, Am Eifeltor 501, 50997 Köln, Rodenkirchen, Germany

2 weeks ago •reported by user-brqd6771

I also receive today a package whitout being ask whith Black wireless headphone and White earplug headphone. What can I do? I dont need this!

Return DI RETURN ONLY, NOT FOR SALES Postlink Am Eifeltor 501, 50997 Köln, Germany

#unorderedpackage #delivery #ameifeltor #koln #nordrheinwestfalen #de

Package whitout being ask photo #1
55

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