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
This recall has been terminated (originally issued May 7, 2008).
- Company
- Convatec
- Recall Initiated
- February 14, 2008
- Posted
- May 7, 2008
- Terminated
- October 21, 2008
- Recall Number
- Z-1179-2008
- Quantity
- 3986 market units
- Firm Location
- Skillman, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot Numbers: 6G4890N, 7C0178N, 7D0529N, 7E1100N, 7F1816N, 7F2009N, 6B2462N, 6E3474N, 6H5767N, 6J5972N and 6L7175N. UPC Code: 30003-020917.
Root Cause
Labeling mix-ups
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.
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