Recall Z-1638-2023 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Medical Systems USA
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
| 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
| K082117 | QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 Maquet Cardiopulmonary, AG, Feb 18, 2009 |