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ESENTA
CONVATEC, PURCHASING DEPARTMENT · Model 423827 · UDI-DI 00768455209484
3
510(k) clearances
32,253
Adverse events (1 deaths)
4
Recalls
84
Facilities
Description
ESENTA THIN XL SEMI CIRCLE (1X20PK) EUR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-29 | ConvaTec, Inc | Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot |
| 2024-08-08 | T.G. Eakin Limited | On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005. |
| 2022-04-22 | ConvaTec, Inc | Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears. |
| 2019-09-06 | ConvaTec, Inc | ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 |
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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.