Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case!
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Add Photo/Video
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by
Loading...
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels - recalled due to Potentially weakened elastic, USA

2 years ago

United States

Company name: Tenacore LLC
Brand name: Tenacore LLC
Product recalled: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Reason of the recall: Potentially weakened elastic
FDA Recall date: April 19, 2021
Recall details: Company Announcement On February 24th, 2021, Tenacore LLC initiated a nationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion. There is a related recall initiated by Becton Dickinson (BD). Information regarding that recall can be found using the following link: Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion | FDA Consumers who have: Tenacore bezel parts (part number TIPA-8100-4410) with timestamp 5 and/or timestamp 6 should stop the distribution and use of these and return them to Tenacore LLC.
Alaris 8100 units that were serviced by Tenacore, or purchased from Tenacore between July 2020 and Feb 2020, should be inspected per the instructions described below to ensure that your device is not impacted. If it is, please return your device to Tenacore LLC.
Recalled bezels were manufactured from May 2020 to June 2020 and distributed from July 2020 through Feb 2021. The following products have been recalled:
Check the full recall details on fda.gov
Source: FDA

304


Related Reports

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: jnjmedtech.com
Source: fda.gov
See Less
303


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: fda.gov
See Less
303


Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and... See More trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in non-sterile product. There have been no reports of patient harm.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

After reviewing the impact of the Nurse Assist recall, Cardinal Health has identified the affected Covidien and Cardinal Health™ brand codes and lot numbers, which you can see in the link below. Customers who received the listed lots were given instructions to:
1. QUARANTINE affected kits/trays.
2. ALERT clinicians of the recalled component(s).
3. AFFIX a WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).
4. NOTIFY other departments, facilities or customers within the customer’s hospital system, if they have transferred the affected kits/trays, and provide a copy of the notice and recall acknowledgement form to them.
5. RETURN their enclosed Acknowledgment Form confirming receipt of this action and the completion of over labeled product.

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: Cardinal Health
Brand name: Covidien and Cardinal Health
Product recalled: Expanded list of Urology and OR room specific kits and trays
Reason of the recall: Potential lack of sterility assurance which could result in non-sterile product
FDA Recall date: February 05, 2024

Source: fda.gov
See Less
303


Aligned Medical Solutions, initiated a nationwide recall of Convenience kits containing saline because the Product cannot be verified as having the required sterility assurance level. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Aligned Medical Solutions distributed these kits... See More nationwide in the USA. Recalled Product(s) were manufactured from 06/028/2022 to 11/20/23 and distributed from 06/08/2022 to 11/27/2023. No injuries have been reported to date.

Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening 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 they are exposed to contaminated water-based medical products.

Recalled products apply to the following kits: AMS10833 Local Lower Extremity Pack I, AMS12947 In-House Ocular Pack, AMS12947A In-House Ocular Pack, and AMS13043 Closure Kit. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Details are attached.

These convenience kits contain the recalled Nurse Assist Sterile Saline, Brand Name - Medline Medical part # DYND40540 110ML Sterile Saline Cup or Nurse Assist Sterile Saline Brand Name - McKesson Medical part # 560284 100ML Sterile Saline Bottle, which has been recalled because the Nurse Assist product cannot be verified as having the required sterility assurance level (SAL) of 10-6. See Nurse Assist Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation

Customers who have affected products should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labeling and replacement products if needed. Customers will be provided with a label that is to be placed on the packs containing the recalled Nurse Assist Sterile Saline. Aligned Medical Solutions is notifying its distributors by email and will arrange for labels to identify the packs with the recalled sterile saline. At the time the kit is opened for use, Nurse Assist sterile saline should be identified, and quarantined according to the medical waste policies in effect in your institution. All other components in the kit are not affected by this recall. Aligned Medical Solutions will also arrange for replacement sterile saline to be sent for all recalled product[s].

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: Aligned Medical Solutions
Brand name: Aligned Medical Solutions
Product recalled: Convenience kits containing saline
Reason for the recall: The product cannot be verified as having the required sterility assurance level
FDA Recall date: January 23, 2024

Source: fda.gov
See Less
303


Getinge / Atrium Medical Corporation notified affected customers of a nationwide recall (medical device correction) for certain Atrium Express Dry Suction Dry Seal Chest Drains in response to a voluntary medical device recall initiated by a supplier, Nurse Assist. On November 8, 2023, Getinge received notice from... See More Nurse Assist, LLC that its Sterile Water, USP, 30mL syringes were being recalled because they could not be verified to be sterile. The affected products were manufactured from November 20, 2020, to September 5, 2023, and distributed from December 18, 2020, through November 8, 2023.

Pre-packaged with every Express chest drain, the 30mL sterile water syringe is intended to fill the air leak monitor chamber for air leak detection during or after initial device set-up, if desired. During a chest drain knock-over event (device not kept in upright position), the water in the air leak monitor chamber could migrate from the air leak monitor chamber to the drainage fluid collection chamber and the patient could potentially be exposed to an infectious pathogen from the water supplied by Nurse Assist. If a patient was already successfully treated with one of the affected Express chest drains, there is no expected negative impact.

The affected Atrium Express Drains are as follows:
Product part number, product name, and UDI Device Identifier:
- 4000-100N, DRAIN, EXPRESS SINGLE W/AC, 00650862115130
- 4050-100N, DRAIN, EXPRESS BRU W/AC, 00650862115147
The affected lot numbers list is attached.

Please examine your inventory immediately to determine if you have any of the Atrium Express Dry Suction Dry Seal Chest Drains with the REF and LOT numbers listed in this notice. Should you have any affected product, please forward this notification to the clinical area(s) of your facility where this product may be used/stored. The LOT Number (6 digit code) can be found on the product label (illustrated in Figures 1 and 2 attached.)

If visualization of active pneumothorax is not needed, keep the affected Express chest drains and set up without water. Use the Express chest drain as intended by replacing the sterile water syringe provided with the drain with a new syringe filled with sterile water using aseptic technique.

Return the affected Express chest drains to Getinge/Atrium Medical Corporation via Return Good Authorization (RGA). If you have any affected Express 4000-100N and/or 4050-100N from the above-listed lots, this product can be returned. If you are a distributor who has shipped any affected products to customers, please forward this information to their attention for appropriate action.

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: Getinge/Atrium Medical Corporation
Brand name: Atrium
Product recalled: Express Drains
Reason of the recall: Syringes provided with Express Drains could not be verified to be sterile.
FDA Recall date: January 04, 2024

Source: fda.gov
See Less
303


A boil water notice in Pottstown has been lifted. The notice had been issued for those in the affected area of a water main break which occurred at High and Wilson Streets.

Source: wfmz.com
Published: 2024-03-18 See Less


Tri-Water System, Inc. has issued a boil advisory for numerous roads in Union Parish, effective immediately due to a water outage. The roads affected are below: Game Reserve Road, Ollie Dawkins Road, Perkins Road, Zion Watts Road, Moshack Road, Bird Road, Meridian Church Road, Burch Road, Andrews... See More Road, Johnny Baker Road, Finch Road, and Highway 348 from Conway Baptist Church to Game Reserve Road.

Source: myarklamiss.com
Published: 2024-03-18
See Less


Water service to a portion of Dunsmuir has been halted following an unscheduled disruption, according to the Shasta County Public Works Department. The Craig View Water System of County Service Area 23 reportedly suffered a "widespread, unscheduled disruption". The Public Works Department says that, once service is... See More restored, they will be issuing a Boil Water Notice to residents.

Source: krcrtv.com
Published: 2024-03-18
See Less


The City of Frederick is preparing for an schedule power outage to repair a substation. It’s going to last about 12 tonight March 19th, until about 6 o’clock in the morning.

Outage link: frederickok.org
Source: kswo.com
Published: 2024-03-18 See Less


Recent Interesting Reports

I ordered plug in portable wall heaters. These people are ridiculous. The state of NY cannot stop these people from ripping everyone off?!?! I cannot get ahold of them? See Less
1.4K


I received a ring from Second Brother
that i did not order 166-10 Metcalf Ave, Flushing, NY 11365. GRA Moissanite. Global Geological Research Academy See Less
7


I ordered 5 products from a facebook page, namely 3 blouses and 2 pairs of pants and received only 3 blouses, which do not correspond either in appearance or size, with a musty smell. When I searched for the email address on awb to return the products, I did not find it. See Less
3


From 7:28PM to 8:29PM on Tuesday 3/12/24, Helicopter heard flying above and around Mililani for 1 hour. They should fly west of Kunia Road or east of H2 freeway if they want to fly in circles without a destination. No street lights no residents there to annoy.... See More
Mililani [21.438º, -158.034º] to [21.444º, -158.005º] to [21.427º, -158.009º]
See Less
44


A package I did not order. Came in today. Not sure what it is, but I need it canceled. Thanks!
Im in Michigan, USA See Less
522


Revived an unordered package. Tried to charge $200. Bank caught it. It’s a white powder. Has anybody analyzed this stuff? See Less
10


Last 30 days