Drug recall
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD…
FDA recall event 62947 · Class II · Maquet Cardiovascular Us Sales, Llc
Key facts
| Event ID | 62947 |
|---|---|
| Recall numbers | Z-0160-2013 |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Product type | Devices |
| Products | QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01%… |
| Initiation date | Jun 12, 2012 |
| Report date | Nov 7, 2012 |
| Termination date | Sep 29, 2017 |
| 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: