Z-1179-2008

Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories...

Name: Z-1179-2008 Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories...
Creator: ConvaTec
Published: 2008-02-14
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2008-02-14 / Terminated / root cause: labeling and UDI

FDA source

ConvaTec began a recall of Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican... on 2008-02-14. The reason FDA records is "Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct". 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-1179-2008
Status: Terminated
Initiated: 2008-02-14
Posted: 2008-05-07
Terminated: 2008-10-21
Recalling firm: ConvaTec Limited
Product: Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558
Product code: EXB Collector, Ostomy
Reason for recall: Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified by an Urgent Product Recall Letter on 2/14/08. Updated letters were issued on 2/21/08 and 4/10/08 with expanded lot numbers. The letters instruct users to return any affected products and a product recall response form. For additional information, contact (908) 904-2199.
Quantity in commerce: 3986 market units
Distribution: Nationwide Distribution.
Product codes and lots: Lot Numbers: 6G4890N, 7C0178N, 7D0529N, 7E1100N, 7F1816N, 7F2009N, 6B2462N, 6E3474N, 6H5767N, 6J5972N and 6L7175N. UPC Code: 30003-020917.

Product code EXB

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)