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SUR-FIT NATURA

CONVATEC, PURCHASING DEPARTMENT · Model 401927 · UDI-DI 00768455104147

FON
3
510(k) clearances
147
Adverse events (1 deaths)
5
Recalls
90
Facilities

Description

SUR-FIT Natura® Little Ones® Drainable Pouch W/1 Sided Comfort Panel, 6" Transparent 1 1/4"

Recalls

DateFirmReason
2026-02-16ConvaTec, IncDrainable large pouch may leak due to manufacturing issue.
2026-02-16ConvaTec, IncDrainable large pouch may leak due to manufacturing issue.
2026-02-16ConvaTec, IncDrainable large pouch may leak due to manufacturing issue.
2024-02-19ConvaTec, IncConvatec 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
2024-01-17ConvaTec, IncThe 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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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.