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HLS Set recallZ-1076-2024 · Maquet Medical Systems USA · initiated Jan 16, 2024

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 Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On January 16, 2024, the recalling firm began notifying affected customers via URGENT MEDICAL DEVICE CORRECTION letters. Customers were instructed to dispose of any Emergency Priming Line from a previously opened, affected HLS set. Customers should only use the Emergency Priming Line from a newly opened HLS Set. Device users should always have an HLS Set ready as a backup during therapy. The remaining components of the backup HLS Set must be disposed of after extraction of the Emergency Priming Line. Please reach out to Getinge Customer Support for the issuance of a replacement HLS Set at no cost. Customers may also return unopened/unexpired affected HLS Sets by contacting Customer Support. If an affected Emergency Priming Line is already in use, the firm advises it should remain in use due to increased potential risk of stopping this emergency procedure. Users should monitor the patient closely for signs of infection. Contact Getinge Customer Support: (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). ***Updated 3/21/24*** Additional lots identified. Firm notified affected customers on March 21, 2024.

Recall details

Recall number
Z-1076-2024
Status
Open, Classified
Initiated by the company
Jan 16, 2024
Posted by the FDA
Feb 13, 2024
Recalling firm
Maquet Medical Systems USA
Quantity
16520 worldwide; 6657 US
Product code
DTZ
FDA submissions
K112360
Distribution
Worldwide - US Nationwide distribution.

Product description

Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.

Code information (models, lots, serial numbers)

UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 ***Added 3/21/24*** 3000333098, 3000352360, 3000357174

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 93849).

Sources and updates

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