Class 3 Device Recall Active Life

• Date Initiated by Firm: July 13, 2006
• Date Posted: August 24, 2006
• Recall Status: Terminated on January 18, 2007
• Recall Number: Z-1432-06
• Recall Event ID: 35927
• 510(K)Number: K833625
• Product Classification: Stomahesive pouch - Product Code LNO
• Product: Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766 Manf. by ConvaTec, Skillman, NJ.
• Code Information: Lot #5H0436N. UPC Code: 30003-022766
• 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 labeled 1-1/4 inch size may contain units that are 1-1/2 inch size.
• FDA Determined Cause: Other
• Action: Notification to all direct customes (tier 1) with letter to tier 1 distributors for tier 2 customers was sent via first class mail on 7/13/06 or direct visit by ConvaTec Sales Reps.
• Quantity in Commerce: 3,857 units
• 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