Z-0073-2011

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

Name: Z-0073-2011 ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican...
Creator: Convatec Inc.
Published: 2010-09-17
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2010-09-17 / Terminated / root cause: labeling and UDI

FDA source

Convatec Inc. began a recall of ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch on 2010-09-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0073-2011
Status: Terminated
Initiated: 2010-09-17
Posted: 2010-10-18
Terminated: 2010-10-19
Recalling firm: ConvaTec Limited
Product: ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch
Product code: EZQ Pouch, Colostomy
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 1 case (20 market units)
Distribution: USA, including IL
Product codes and lots: Product order number: 125333, Lot number: 0G01881

Product code EZQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)