Device product
QUADROX-i oxygenators Custom tubing packs for the oxygenator
Z-1371-2016
Product summary
- Event
- Event 73390
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72,000 units in total
- Official record key
device-enforcement:Z-1371-2016
Official wording
Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Code information: All sizes and membrane types of QUADROX-i oxygenators, QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; BE-HMOD xxxxx, BEQ-HMO xxxxx, BEQ-HMOD xxxxx, BO-VKMO xxxxx, HMO xxxxx, HMOD xxxxx, VKMO xxxxx, X HMO xxxxx U, X HMOD 30000 U, X VKMO xxxxx U, and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating; XVIVO HMO 70100
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.