Maquet Medical Systems USA Recall 92003
Description: QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Maquet Medical Systems USA Recall 92003 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1641-2023 |
| Event ID | 92003 |
| Event Description | QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. |
| Quantity | 0 (US) |
| Recall 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. |
| Device Classification | 20230607 |
| Device Code Info | Model Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 All lots |
| Center Classification Date | 20230526 |
| Recall Initiation Date | 20230518 |
| Recalling Firm | Maquet Medical Systems USA |
| Initial Notification | Letter |
| Similar To |