GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2
FDA device recall Z-1314-2008 · posted 2008-07-02 · Terminated
Recall details
- Recalling firm
- ConvaTec
- 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."
- Action taken
- 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
- Status
- Terminated
- Product code
- EXB
- Quantity affected
- 9,299 units
- Distribution
- Worldwide Distribution including USA and country of Canada.
- Date initiated
- 2008-03-07
- Date posted
- 2008-07-02
- Date terminated
- 2008-10-21
- Location
- Skillman, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.