Drug recall
SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802…
FDA recall event 78507 · Class II · ConvaTec, Inc
Key facts
| Event ID | 78507 |
|---|---|
| Recall numbers | Z-0525-2018 |
| Recalling firm | ConvaTec, Inc |
| Product type | Devices |
| Products | SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin… |
| Initiation date | Oct 26, 2017 |
| Report date | Feb 14, 2018 |
| Termination date | Feb 3, 2023 |
| 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: