Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2016 - (Recall #: Z-1371-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

QUADROX-i oxygenators Custom tubing packs for the oxygenator

Product Classification:

Class II

Date Initiated: February 23, 2016

Date Posted: April 20, 2016

Recall Number: Z-1371-2016

Event ID: 73390

Reason for Recall:

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

Status: Terminated

Product Quantity: 72,000 units in total

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.

Voluntary or Mandated:

Voluntary: Firm initiated