ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTe
FDA device recall Z-0073-2011 · posted 2010-10-18 · Terminated
Recall details
- Recalling firm
- Convatec Inc.
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- EZQ
- Quantity affected
- 1 case (20 market units)
- Distribution
- USA, including IL
- Date initiated
- 2010-09-17
- Date posted
- 2010-10-18
- Date terminated
- 2010-10-19
- Location
- Skillman, NJ
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