Drug recall
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part…
FDA recall event 68951 · Class II · Civco Medical Instruments Inc
Key facts
| Event ID | 68951 |
|---|---|
| Recall numbers | Z-2558-2014 |
| Recalling firm | Civco Medical Instruments Inc |
| Product type | Devices |
| Products | CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product. |
| Initiation date | Aug 1, 2014 |
| Report date | Sep 3, 2014 |
| Termination date | Jan 28, 2015 |
| City | Kalona |
| State | IA |
| Country | United States |
| FEI number | 1937223 |
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: