FDAFebruary 19, 2024device

Convatec 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) 423661

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Convatec 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 filter weld.

What to do

FDA enforcement status: Ongoing

Brands named

convatec

UPCs

768455203925768455204076768455204083768455204137768455204151976845520394768455204168768455204069768455204014768455203956768455204038768455204021

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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