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QUADROX-iR, used during cardiopulmonary bypass recallZ-1643-2023 · Maquet Medical Systems USA · initiated May 18, 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

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

FDA root cause category: Pending

What the company is doing

On May 18, 2023, the firm notified customers of the recall via an Urgent Medical Device Removal letter. Actions to be taken by the customer: If an affected device is already in use, please use according to normal practices. Monitor the patient for signs and symptoms of inflammation, infection, sepsis, and ischemia. If detected, treat according to clinical protocols. Please remove any affected product in inventory from areas of use. Unopened and unexpired affected product is eligible for credit upon return. Product Return: Please contact Getinge Customer Service at 1-888-943-8872 option 2 between the hours of 6:00 AM and 5:00 PM Pacific Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Distributors who have shipped affected products to customers should forward the notification to customers' attention for appropriate action. Maquet Cardiopulmonary GmbH is working with all possible urgency on the redesign and revalidation of a packaging solution, which is anticipated to be available by Q4 2023.

Recall details

Recall number
Z-1643-2023
Status
Open, Classified
Initiated by the company
May 18, 2023
Posted by the FDA
May 26, 2023
Recalling firm
Maquet Medical Systems USA
Quantity
0 (US)
Product code
DTQ
FDA submissions
K102726
Distribution
Domestic distribution nationwide.

Product description

QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

Code information (models, lots, serial numbers)

Model Item No. UDI-DI BEQ-HMO 51100-USA 701067936 n/a BEQ-HMO 71100-USA 701067880 4058863164052 HMO 50100-USA 701067934 n/a HMO 51100-USA 701067938 n/a HMO 70100-USA 701067874 n/a HMO 71100-USA 701067886 n/a All lots

Other devices under the same FDA submission

1 device cleared under K102726 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92003).

Sources and updates

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