FDA Recall
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.
Recall: Z-0870-2015
·
Initiated November 5, 2014
Recall
- Recall Number
- Z-0870-2015
- Event Number
- 69795
- Firm
- Maquet Cardiovascular Us Sales, Llc
- FEI Number
- 3008355164
- Product Code
- DTZ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 5, 2014
- Posted
- December 24, 2014
- Terminated
- July 24, 2015
- Address
- 45 Barbour Pond Drive, Wayne, NJ, 07470
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
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.
Action
Maquet Inc. sent Urgent Product Recall - Removal Letters/Response Forms dated 11/5/2014.
Distribution
Distributed in DC, MA, & MI.
Quantity
28 units