Recall Z-1076-2024 ยท DTZ Oxygenator, Cardiopulmonary Bypass
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.
| Date | Feb 13, 2024 (initiated Jan 16, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 16520 worldwide; 6657 US |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112360 | QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES Maquet Cardiopulmonary, AG, Sep 15, 2011 |