Recall Z-1661-2023 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Medical Systems USA
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
| 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
| K102919 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE Maquet Cardiopulmonary, AG, Mar 11, 2011 |