Drug recall
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For…
FDA recall event 69795 · Class II · Maquet Cardiovascular Us Sales, Llc
Key facts
| Event ID | 69795 |
|---|---|
| Recall numbers | Z-0870-2015 |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 5, 2014 |
| Report date | Dec 31, 2014 |
| Termination date | Jul 24, 2015 |
| City | Wayne |
| State | NJ |
| Country | United States |
| FEI number | 3008355164 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: