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Recall Observatory FDA recall evidence

Device product

QUADROX-i oxygenators Custom tubing packs for the oxygenator

Z-1371-2016

February 23, 2016

Class II

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
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

    reason.no_named_rule · v1.0.0

    Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.