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

Skip this step

Add photos or video

We recommend photos and videos to help explain your report

Add Photo/Video
Skip this step

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

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

Safety Report: Atrium Express Drains - recalled due to unverified sterility of provided syringes, USA

5 months ago source fda.gov

Recall notice

United States

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 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: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/getinge-atrium-medical-corporation-issues-medical-device-correction-nurse-assist-syringes-provided

#medicaldevices #recall #us

Recent Interesting Reports

T
I ordered some clothes that I still haven't received yet but I received a ring instead. It says to scan this QR code to register it. I thankfully didn't do that because I wonder if that somehow takes my money? It came from Angelo Want

#scam #onlineshopping #onlinescam #delivery #5549arrowhighway #montclair #california #us

Bags of TDBBS Bully Sticks recalled due to metal contamination, USA

1 week ago source accessdata.fda.gov details

Recall notice

TDBBS, LLC has voluntarily initiated a recall of its Best Bully Stick and Barkworthies branded Green Tripe Bully Sticks due to potential foreign material contamination. The products have been distributed nationwide. The issue was discovered due to the presence of foreign material, specifically metal, in the product.… See more

#us

G
I keep receiving shipments from Slimfit Fusion that I have not ordered. It comes in a white envelope with no information but Data Press, 1400 Shattuck Ave Suite 12, Berkeley CA 94709 is the return address. I did not subscribe to this and I do not want… See more

#ketogummiesscam #unorderedpackage #delivery #berkeley #california #us

Last 30 days