Drug recall
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957)…
FDA recall event 88460 · Class II · ConvaTec, Inc
Key facts
| Event ID | 88460 |
|---|---|
| Recall numbers | Z-2519-2021 |
| Recalling firm | ConvaTec, Inc |
| Product type | Devices |
| Products | DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for open seals which can compromise sterility. |
| Initiation date | Aug 9, 2021 |
| Report date | Sep 29, 2021 |
| City | Greensboro |
| State | NC |
| Country | United States |
| FEI number | 3011987967 |
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: