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MAQUET CARDIOHELP recallZ-1053-2024 · Maquet Medical Systems USA · initiated Dec 28, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Medical Systems USA or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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 [email protected] 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).

Recall details

Recall number
Z-1053-2024
Status
Open, Classified
Initiated by the company
Dec 28, 2023
Posted by the FDA
Feb 8, 2024
Recalling firm
Maquet Medical Systems USA
Quantity
274 units (70 US, 204 OUS)
Product code
DTQ
FDA submissions
K133598
Distribution
AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.

Product description

Bubble Sensor (REF: 70105.5720)

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model: BS 3/8x3/32 L1.7; Correct UDI DI: 04037691816432; Incorrect UDI DI (as labeled): 04058863025148; SNs: 90041799 90041816 90041938 90042009 90042069 90041802 90041817 90041939 90042011 90042070 90041804 90041818 90041940 90042036 90042071 90041805 90041821 90041943 90042037 90042074 90041806 90041822 90041957 90042038 90042076 90041807 90041823 90041963 90042042 90042079 90041808 90041826 90041966 90042049 90042083 90041809 90041836 90041974 90042050 90042085 90041810 90041898 90041983 90042054 90042089 90041811 90041905 90041993 90042056 90042090 90041812 90041907 90041994 90042058 90042092 90041813 90041921 90041995 90042060 90042093 90041814 90041925 90041997 90042063 90042094 90041815 90041930 90042005 90042066 90042097;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K133598 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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