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Terminated

GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.

FDA Recall Z-1314-2008 · Posted 2008-07-02

Recalling FirmConvaTec
Recall StatusTerminated
Product CodeEXB
Date Initiated2008-03-07
Date Terminated2008-10-21
Product Quantity9,299 units

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."

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution including USA and country of Canada.

Official Source

View FDA Recall →

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

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