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HOLLISTER INCORPORATED · Model 19613 · UDI-DI 00610075098521
0
510(k) clearances
1
Adverse events
1
Recalls
22
Facilities
Description
Colostomy/Illeostomy Kit, CeraPlus, Soft Convex, Drainable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-10-26 | ConvaTec, Inc | 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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.