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U.S. Department of Health and Human Services

Class 3 Device Recall ActiveLife

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  Class 3 Device Recall ActiveLife see related information
Date Initiated by Firm July 31, 2006
Date Posted September 27, 2006
Recall Status1 Terminated 3 on May 10, 2007
Recall Number Z-1532-06
Recall Event ID 36268
510(K)Number K840568  
Product Classification ostomy pouch - Product Code LNO
Product ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60)
1 3/4 in. 45 mm
Code Information REF 413145; UPC 0034 13145 Lot #6E3589N
Recalling Firm/
Manufacturer		 ConvaTec
200 Headquarters Park Dr
Skillman NJ 08558-2624
For Additional Information Contact Karen Krenta
908-904-2071
Manufacturer Reason
for Recall		 Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label.
FDA Determined
Cause 2		 Other
Action A recall notification was mailed by first class mail on 7/31/2006 to all direct customers with letter to tier 1 distributors for tier 2 end users.
Distribution Nationwide
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.
510(K) Database 510(K)s with Product Code = LNO and Original Applicant = CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
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