Class 3 Device Recall ActiveLife OnePiece Drainable Pouch 32mm

• Date Initiated by Firm: September 17, 2010
• Date Posted: October 18, 2010
• Recall Status: Terminated on October 19, 2010
• Recall Number: Z-0073-2011
• Recall Event ID: 56789
• Product Classification: Pouch, colostomy - Product Code EZQ
• Product: ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier;; 1 1/4 in., 32mm;; Made in Dominican Republic;; ConvaTec.; Colostomy pouch
• Code Information: Product order number: 125333, Lot number: 0G01881
• Recalling Firm/ Manufacturer: Convatec Inc.; 200 Headquarters Park Drive; Skillman NJ 08558-2600
• For Additional Information Contact: Karen Karenta; 800-422-8811
• Manufacturer Reason for Recall: Mislabeled: the market units were incorrectly labeled as # 125339 ActiveLife Drainable Pouch 25 mm; the product inside was actually ActiveLife Pouch Small Tan 32 mm, ICC # 125333.
• FDA Determined Cause: Labeling mix-ups
• Action: ConvaTec, Inc. sent a Returned Goods Authorization form by e-mail dated September 3, 2010, to one customer. The form identified the product, the problem, and the action the customer should take. The customer was instructed to detach the label and affix it to the outside of the box, copy the RGA # and retain a copy for their records, enclose the completed form and return with the product, For questions call (908) 904-2675.
• Quantity in Commerce: 1 case (20 market units)
• Distribution: USA, including IL
• Total Product Life Cycle: TPLC Device Report

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.