Bubble Sensor (REF: 70105.5720)

FDA device recall Z-1053-2024 · posted 2024-02-08 · Open, Classified

Recall details

Recalling firm

Maquet Medical Systems USA

Reason for recall

The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

Action taken

An Urgent Medical Device Correction Letter was sent VIA Fed-Ex 2-day delivery with signature proof of delivery to all consignees with the following instructions: Actions to be taken by the Customer: - Please examine your inventory immediately to determine if you have any affected product in your inventory. - Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE - CORRECTION RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to BubbleSensorUDI2023.cp@getinge.com or by faxing the form to 1-866-416-5299. - Affected Bubble Sensors do not need to be returned and can be used as-is. - Please forward this information to all current and potential Bubble Sensor users within your hospital / facility. - If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or call Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

Root cause

Labeling mix-ups

Status

Open, Classified

Product code

DTQ

Quantity affected

274 units (70 US, 204 OUS)

Distribution

AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.

Date initiated

2023-12-28

Date posted

2024-02-08

Location

Wayne, NJ

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