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ESTEEM
CONVATEC, PURCHASING DEPARTMENT · Model 423666 · UDI-DI 00768455204151
3
510(k) clearances
147
Adverse events (1 deaths)
5
Recalls
90
Facilities
Description
N/A
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-16 | ConvaTec, Inc | Drainable large pouch may leak due to manufacturing issue. |
| 2026-02-16 | ConvaTec, Inc | Drainable large pouch may leak due to manufacturing issue. |
| 2026-02-16 | ConvaTec, Inc | Drainable large pouch may leak due to manufacturing issue. |
| 2024-02-19 | ConvaTec, Inc | Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the |
| 2024-01-17 | ConvaTec, Inc | The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring. |
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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.