PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 31, 2014 Initiated: November 5, 2014 #Z-0870-2015

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.

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.

Details

Units Affected
28 units
Distribution
Distributed in DC, MA, & MI.
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 28 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 31, 2014. Severity: Moderate. Recall number: Z-0870-2015.