Drug recall
CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with…
FDA recall event 70719 · Class II · Civco Medical Instruments Inc
Key facts
| Event ID | 70719 |
|---|---|
| Recall numbers | Z-1400-2015 |
| Recalling firm | Civco Medical Instruments Inc |
| Product type | Devices |
| Products | CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Leaks were detected in the recalled lot which may compromise the sterility of the product. |
| Initiation date | Feb 26, 2015 |
| Report date | Apr 15, 2015 |
| Termination date | Feb 28, 2017 |
| 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: