Home › Device types › EXE
Protector, Ostomy
FDA product code EXE · Class 1 · Gastroenterology, Urology
409
Registered devices
32,253
Adverse events
4
Recalls
3
510(k) clearances
Devices with this code
AMPatch Stoma Cover — Austin Medical Products, Inc.Adapt CeraRing — HOLLISTER INCORPORATEDAMPatch Stoma Cover — Austin Medical Products, Inc.AMPatch Stoma Cover — Austin Medical Products, Inc.AMPatch Stoma Cover — Austin Medical Products, Inc.AMPatch Stoma Cover — Austin Medical Products, Inc.AMPatch Stoma Cover — Austin Medical Products, Inc.ESTEEM SYNERGY — CONVATEC, PURCHASING DEPARTMENTAMPatch Stoma Cover — Austin Medical Products, Inc.AMPatch Stoma Cover — Austin Medical Products, Inc.AMPatch Stoma Cover — Austin Medical Products, Inc.SUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENTSUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENTSUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENTAdapt CeraRing — HOLLISTER INCORPORATEDSTOMAHESIVE — CONVATEC, PURCHASING DEPARTMENTAMPatch Stoma Cover — Austin Medical Products, Inc.SUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENTSUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENTEakin — T.G. EAKIN LIMITEDAMPatch Stoma Cover — Austin Medical Products, Inc.AMPatch Stoma Cover — Austin Medical Products, Inc.AMPatch Stoma Cover — Austin Medical Products, Inc.Eakin — T.G. EAKIN LIMITED
Recent 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 b |
| 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 |
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