Recall Z-1766-2022 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Medical Systems USA
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.
| Date | Jul 22, 2022 |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Package design/selection |
| Action | 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 |
| Quantity | 6,871 US; 18,670 worldwide |
| Distribution | Worldwide distribution - US Nationwide and the countries Canada and Australia. |
| 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 |