Recall Z-1662-2023 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Medical Systems USA
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 5
| Date | May 30, 2023 (initiated May 18, 2023) |
| Status | Open, Classified |
| Reason | Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia. |
| Root cause | Under Investigation by firm |
| Action | On May 18, 2023, the firm notified customers of the recall via an Urgent Medical Device Removal letter. Actions to be taken by the customer: If an affected device is already in use, please use according to normal practices. Monitor the patient for signs and symptoms of inflammation, infection, sepsis, and ischemia. If detected, treat according to clinical protocols. Please remove any affected product in inventory from areas of use. Unopened and unexpired affected product is eligible for credit upon return. Product Return: Please contact Getinge Customer Service at 1-888-943-8872 opti |
| Quantity | 0 (US) |
| Distribution | Nationwide domestic distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102726 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, Apr 4, 2011 |