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ESTEEM+

CONVATEC, PURCHASING DEPARTMENT · Model 416700 · UDI-DI 00768455111701

EZQ
6
510(k) clearances
2,020
Adverse events (1 deaths)
5
Recalls
49
Facilities

Description

Esteem®+ One-Piece Cut-To-Fit Closed-End Pouch, Modified Stomahesive, Filter, One-Sided Comfort Panel, 8" Transparent, 2 2/5" By 2 3/4" (60/70Mm)

Recalls

DateFirmReason
2022-08-16ConvaTec, Incimpaired functionality of the release liner
2022-08-16ConvaTec, Incimpaired functionality of the release liner
2022-08-16ConvaTec, Incimpaired functionality of the release liner
2022-08-16ConvaTec, Incimpaired functionality of the release liner
2010-09-17Convatec Inc.Mislabeled: the market units were incorrectly labeled as # 125339 ActiveLife Drainable Pouch 25 mm; the product inside was actually ActiveLife Pouch Small Tan 32 mm, ICC # 125333.

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Data 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.