FDA Enforcement
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.
Recall: Z-0870-2015
·
Reported December 31, 2014
Enforcement
- Recall Number
- Z-0870-2015
- Event ID
- 69795
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Maquet Cardiovascular Us Sales, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 31, 2014
- Initiation Date
- November 5, 2014
- Classification Date
- December 23, 2014
- Termination Date
- July 24, 2015
- Address
- 45 Barbour Pond Drive, Wayne, NJ, 07470, United States
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.
Code Info
k100278 Lot number 70100610
Distribution
Distributed in DC, MA, & MI.
Quantity
28 units