Z-1314-2008

GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number...

Name: Z-1314-2008 GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number...
Creator: ConvaTec
Published: 2008-03-07
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2008-03-07 / Terminated / root cause: labeling and UDI

FDA source

ConvaTec began a recall of GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ... on 2008-03-07. The reason FDA records is "Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure."". 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-1314-2008
Status: Terminated
Initiated: 2008-03-07
Posted: 2008-07-02
Terminated: 2008-10-21
Recalling firm: ConvaTec Limited
Product: GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.
Product code: EXB Collector, Ostomy
Reason for recall: Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure."
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified by an Urgent Product Recall letter sent on 3/7/08. The letter instructed users to return any unused affected product to the recalling firm for a credit. For additional information, contact 1-800-422-8811.
Quantity in commerce: 9,299 units
Distribution: Worldwide Distribution including USA and country of Canada.
Product codes and lots: Lot Numbers: 7G29699, 7G30740, 7G31418, 7H22693, 7H24608, 7J30626, 7J32192 and 7K30871. Lot numbers 7L27391, 8A33519 and 8A37099 are also affected, however they have not been distirbuted.

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)