Maquet Medical Systems USA Recall 92006
Description: QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
Maquet Medical Systems USA Recall 92006 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1657-2023 |
| Event ID | 92006 |
| Event Description | QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895 |
| Product Type | Devices |
| Distribution | Nationwide domestic distribution |
| Quantity | 1,784 (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-DI BEQ-HMO 50000-USA 701067905 4058863019079 HMO 50000-USA 701067891 4058863019055 HMO 51000-USA 701067895 4058863019185 All lots |
| Center Classification Date | 20230530 |
| Recall Initiation Date | 20230518 |
| Recalling Firm | Maquet Medical Systems USA |
| Initial Notification | Letter |
| Similar To |