Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac s
FDA device recall Z-0870-2015 · posted 2014-12-24 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- 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.
- Action taken
- Maquet Inc. sent Urgent Product Recall - Removal Letters/Response Forms dated 11/5/2014.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 28 units
- Distribution
- Distributed in DC, MA, & MI.
- Date initiated
- 2014-11-05
- Date posted
- 2014-12-24
- Date terminated
- 2015-07-24
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA (K100278) | Maquet Cardiopulmonary, AG | 2010-04-30 |