Maquet Medical Systems USA Recall 92006
Description: QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Maquet Medical Systems USA Recall 92006 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1660-2023 |
| Event ID | 92006 |
| Event Description | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416 |
| Product Type | Devices |
| Distribution | Nationwide domestic distribution |
| Quantity | 0 (US) |
| Recall 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. |
| Device Classification | 20230607 |
| Device Code Info | Model Item No. UDI HMO 10000-USA 701070412 4058863154473 HMO 11000-USA 701070416 4058863154558 All lots |
| Center Classification Date | 20230530 |
| Recall Initiation Date | 20230518 |
| Recalling Firm | Maquet Medical Systems USA |
| Initial Notification | Letter |
| Similar To |