FDAApril 22, 2022device
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
What to do
FDA enforcement status: Terminated
Brands named
convatec
UPCs
00768455106189
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAConvatec, EsteemBody Drainable Pouch REF:423653 10-35mm2026-02-16
- FDAConvatec, EsteemBody Drainable Pouch REF:423657 10-35mm2026-02-16
- FDAConvatec, EsteemBody Drainable Pouch REF:423643, 10-45mm2026-02-16
- FDADuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dress...2025-08-29
- FDAEsteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 4054792024-11-29
- FDAConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.2024-02-27
- FDAConvatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 4236612024-02-19
- FDAConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.2024-01-17
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