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HLS Set recallZ-1766-2022 · Maquet Medical Systems USA · initiated Jul 22, 2022

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 firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

FDA root cause category: Package design/selection

What the company is doing

On July 15, 2022, the firm notified affected customers via Urgent Medical Device Removal Expansion letter. The letter informed customers of the inclusion of additional product codes and lots into the earlier recall initiated on November 6, 2020. Customers were instructed to examine their inventory and identify any affected product on hand. Affected product in use may be continued to be used according to normal practices. Unused and unexpired affected product should be immediately returned to Getinge for credit. Please contact Getinge Customer Service at (888) 9GETUSA / (888) 943-8872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. At this time, the recalling firm has already implemented the more durable Tyvek accessory packaging in all product manufactured September 2021 and later.

Recall details

Recall number
Z-1766-2022
Status
Open, Classified
Initiated by the company
Jul 22, 2022
Recalling firm
Maquet Medical Systems USA
Quantity
6,871 US; 18,670 worldwide
Product code
DTZ
FDA submissions
K112360
Distribution
Worldwide distribution - US Nationwide and the countries Canada and Australia.

Product description

BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

Code information (models, lots, serial numbers)

UDI-DI: 04058863076355 Lots 3000192081, 3000193363, 3000196200, 3000208697, 3000216172

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

3 devices cleared under K112360 are not named by identifier in this recall. 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 90740).

Sources and updates

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