Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2014 - (Recall #: Z-0870-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.

Product Classification:

Class II

Date Initiated: November 5, 2014

Date Posted: December 31, 2014

Recall Number: Z-0870-2015

Event ID: 69795

Reason for Recall:

Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels.

Status: Terminated

Product Quantity: 28 units

Code Information:

k100278 Lot number 70100610

Distribution Pattern:

Distributed in DC, MA, & MI.

Voluntary or Mandated:

Voluntary: Firm initiated