Recall Z-0073-2011 ยท EZQ Pouch, Colostomy
Convatec Inc.
ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch
| Date | Oct 18, 2010 (initiated Sep 17, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 1 case (20 market units) |
| Distribution | USA, including IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.