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Terminated

ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch

FDA Recall Z-0073-2011 · Posted 2010-10-18

Recalling FirmConvatec Inc.
Recall StatusTerminated
Product CodeEZQ
Date Initiated2010-09-17
Date Terminated2010-10-19
Product Quantity1 case (20 market units)

Reason for Recall

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.

Firm Action

ConvaTec, Inc. sent a Returned Goods Authorization form by e-mail dated September 3, 2010, to one customer. The form identified the product, the problem, and the action the customer should take. The customer was instructed to detach the label and affix it to the outside of the box, copy the RGA # and retain a copy for their records, enclose the completed form and return with the product, For questions call (908) 904-2675.

Root Cause

Labeling mix-ups

Distribution Pattern

USA, including IL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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