Drug recall
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally…
FDA recall event 66365 · Class II · Maquet Cardiovascular, LLC
Key facts
| Event ID | 66365 |
|---|---|
| Recall numbers | Z-0001-2014 |
| Recalling firm | Maquet Cardiovascular, LLC |
| Product type | Devices |
| Products | Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176… |
| Initiation date | Sep 20, 2013 |
| Report date | Oct 9, 2013 |
| Termination date | Jun 10, 2014 |
| City | Wayne |
| State | NJ |
| Country | United States |
| FEI number | 2242352 |
At a glance
- 1–9 Products in this recall
- 10–99 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: