Drug recall
MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and…
FDA recall event 64919 · Class II · Owens & Minor Distribution, Inc.
Key facts
| Event ID | 64919 |
|---|---|
| Recall numbers | Z-1192-2013 |
| Recalling firm | Owens & Minor Distribution, Inc. |
| Product type | Devices |
| Products | MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from… |
| Initiation date | Mar 26, 2013 |
| Report date | May 8, 2013 |
| Termination date | Oct 31, 2014 |
| City | Mechanicsville |
| State | VA |
| Country | United States |
| FEI number | 3003753847 |
At a glance
- 1–9 Products in this recall
- None 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: