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

FDA device recall Z-1076-2024 · posted 2024-02-13 · Open, Classified

Recall details

Recalling firm

Maquet Medical Systems USA

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

DTZ

Quantity affected

16520 worldwide; 6657 US

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2024-01-16

Date posted

2024-02-13

Location

Wayne, NJ

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