Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Ord
FDA device recall Z-1179-2008 · posted 2008-05-07 · Terminated
Recall details
- Recalling firm
- ConvaTec
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- EXB
- Quantity affected
- 3986 market units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-02-14
- Date posted
- 2008-05-07
- Date terminated
- 2008-10-21
- Location
- Skillman, NJ
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