Recall Z-1637-2023 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Medical Systems USA
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
| Date | May 26, 2023 (initiated May 18, 2023) |
| Status | Open, Classified |
| Reason | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia. |
| Root cause | Pending |
| 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 option 2 b |
| Quantity | 0 (US) |
| Distribution | Domestic distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090689 | QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 Maquet Cardiopulmonary, AG, Oct 29, 2009 |