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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 ActiveLifesee related information
Date Initiated by FirmJuly 31, 2006
Date PostedSeptember 27, 2006
Recall Status1 Terminated 3 on May 10, 2007
Recall NumberZ-1531-06
Recall Event ID 36268
510(K)NumberK840568 
Product Classification ostomy pouch - Product Code LNO
ProductActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15) 1 3/4 in. 45 mm
Code Information REF 175772; UPC 00031 75772; Lot # 6E3586N
Recalling Firm/
Manufacturer
ConvaTec
200 Headquarters Park Dr
Skillman NJ 08558-2624
For Additional Information ContactKaren 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
ActionA 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.
DistributionNationwide

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) Database510(K)s with Product Code = LNO
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