FDA Medical Device Recalls (openFDA)
Maquet Medical Systems USA: Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
- Recall number
- Z-1076-2024
- Recalling firm
- Maquet Medical Systems USA
- Product
- Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
- Status
- Open, Classified
- Initiated
- 2024-01-16
- Posted
- 2024-02-13
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 16520 worldwide; 6657 US
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 ***Added 3/21/24*** 3000333098, 3000352360, 3000357174
- 510(k) numbers
- ["K112360"]
- PMA numbers
- not on file
- Product code
- DTZ
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28