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.
FDA Recall Z-0870-2015 · Posted 2014-12-24
Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeDTZ
Date Initiated2014-11-05
Date Terminated2015-07-24
Product Quantity28 units
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.
Firm Action
Maquet Inc. sent Urgent Product Recall - Removal Letters/Response Forms dated 11/5/2014.
Root Cause
Process control
Distribution Pattern
Distributed in DC, MA, & MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.