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Vyaire Medical ventilators - recalled due technical failure alarm, USA

2 years ago

United States

Imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305. There is a potential issue with bellavista™ 1000 and 1000e ventilators that have software version 6.0.1600.0 or higher installed, which was deployed in February 2021, and also have the Data Communication port set to “HL7”.

Customers with software version 6.0.1600.0 or higher installed have been notified by Vyaire to immediately disable the HL7 data communication if activated. If the HL7 data communication is not disabled, such devices are at risk of the reported unintentional ceasing of ventilation. This decision is based on the receipt of reports that some bellavista™ 1000 and 1000e ventilators have unintentionally ceased ventilation during clinical use and require rebooting to resume ventilation due to a software issue. An internal investigation determined that bellavista 1000 and 1000e ventilators with software version 6.0.1600.0 or higher installed can have a conflict in memory resource allocation between software tasks when the Data Communication port is set to “HL7”.

The ventilator notifies the user of the issue by triggering technical failure alarm 305 indicating an interruption in the communication between the user interface controller (EPC) and the ventilation controller (CFB). No patient harm has been reported related to this issue.

If clinicians operate a bellavista™ ventilator and do not set Data Communication port to “HL7”, this error will not occur. Therefore, Vyaire supports the continued use of these devices and directs customers to follow the instructions provided in the Company’s correction notification to immediately disable the HL7 data communication if activated while the company develops and deploys a software update to address the issue, anticipated in Q1 of calendar year 2022.

The affected ventilators were distributed to medical facilities in the US between 3/21/19 through 12/23/21 located in the following states: AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, PR SD, TX, VA, WA, WI and WV.

Company name: Vyaire Medical
Brand name: bellavista™
Product recalled: ventilators
Reason of the recall: Ventilators can cease ventilation and generate a technical failure alarm 305
FDA Recall date: February 04, 2022

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vyaire-medical-issues-voluntary-correction-certain-bellavistatm-ventilators-specific-software

Source: FDA

303


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Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can... See More result in an over-potent dosing regimen. The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors. The Lots were distributed between 11/09/2023 and 2/20/2024. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL.
- Pack Size: 80 mL, Expiration Date: 09/2025, Lot: 22613003A, NDC No.: 69238-2261-3.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613004A, NDC No.: 69238-2261-7.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613005A, NDC No.: 69238-2261-7.
- Pack Size: 300 mL, Expiration Date: 09/2025, Lot: 22613005B, NDC No.: 69238-2261-5.

Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots.

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: Amneal Pharmaceuticals, LLC.
Brand name: Amneal
Product recalled: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
Reason of the recall: Super potent due to bottles being overfilled
FDA Recall date: March 27, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution
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303


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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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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Several brands of folic acid tablets have been recalled in Canada due to concerns that affected lots may exceed the acceptable intake limit for N-nitroso-folic acid. The recall involves multiple brands distributed across the country.

-Affected products
Brand: Compliments FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG,... See More Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHH
Brand: Equate FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115LRJ & 2G3115NHF
Brand: Health One FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NJL
Brand: Nature's Bounty FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2340T8130A
Brand: Pharmasave FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHG
Brand: Sisu FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115M1C

Consumers are advised to consult their healthcare provider if they have any health concerns related to this recall.

Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca/en/alert-recall/folic-acid-1mg-affected-lots-exceed-or-may-exceed-acceptable-intake-limit-n-nitroso
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Central Valley Ag Cooperative has voluntarily recalled its GS Hamster/Gerbil + Turmeric food due to a potential Salmonella contamination. The recall affects both animals and humans and is currently ongoing. The recalled product has been distributed in Kansas.

The recalled product is GS Hamster/Gerbil + Turmeric, sold... See More in bulk super sacks. A total of 7,464 pounds of the product, bearing the lot number B0624179808 11399 OXBOW and a best before date of 2/6/2026, have been recalled.

The recall was initiated after an ingredient in the gerbil/hamster feed tested positive for Salmonella.

The issue was discovered during routine testing by the company. The recall was initiated on February 26, 2024.

In case you are experiencing Salmonella symptoms such as diarrhea, abdominal cramps, and fever, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: www.accessdata.fda.gov/scripts/ires/index.cfm?Product=206422
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On Thursday 28th, SDG&E reported another outage affecting almost 8,000 customers in the neighborhoods of Nestor, San Ysidro and Otay Mesa. The initial restoration time was listed as 2:30 p.m. At 1:20 p.m., all power in these areas was reported to be back on.

Outage link: www.sdge.com/residential/-service/outage-center/outage-map... See More
Source: www.yahoo.com/news/thousands-sdg-e-customers-left-180934562.html
Published: 2024-03-28
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Hundreds of Duquesne Light customers are without power this morning after a car slammed into a pole in Center Township, Beaver County overnight. Duquesne Light’s outage website says that nearly 600 customers across Center Township and Hopewell Township are without power this morning Friday 29th.

Outage link:... See More www.duquesnelight.com/outages-safety/current-outages
Source: www.yahoo.com/news/hundreds-without-power-car-crashes-103229253.html
Published: 2024-03-29
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The Town of Odon advises Oak Street from Main to Race Streets will have water shut off Friday 29th for 4-6 hours during the day. Anyone affected will be on a boil order until further notice.

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