| Class 3 Device Recall Active Life Little Ones OnePiece Custom Urostomy Pouch 5/16 1 inch, 825mm | |
Date Initiated by Firm | February 14, 2008 |
Date Posted | May 07, 2008 |
Recall Status1 |
Terminated 3 on October 21, 2008 |
Recall Number | Z-1179-2008 |
Recall Event ID |
46802 |
Product Classification |
Ostomy pouch and accessories - Product Code EXB
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Product | 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 |
Code Information |
Lot Numbers: 6G4890N, 7C0178N, 7D0529N, 7E1100N, 7F1816N, 7F2009N, 6B2462N, 6E3474N, 6H5767N, 6J5972N and 6L7175N. UPC Code: 30003-020917. |
Recalling Firm/ Manufacturer |
ConvaTec 200 Headquarters Park Dr Skillman NJ 08558-2624
|
For Additional Information Contact | Karen Krenta 732-904-2071 |
Manufacturer 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. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | 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. |
Quantity in Commerce | 3986 market units |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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