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U.S. Department of Health and Human Services

Class 2 Device Recall VICRYL RAPIDE

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  Class 2 Device Recall VICRYL RAPIDE see related information
Date Initiated by Firm August 11, 2008
Date Posted October 02, 2008
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-0021-2009
Recall Event ID 49435
510(K)Number K033746  K962480  K944110  
Product Classification Suture - Product Code GAM
Product VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP.
Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876

The product is used for Soft Tissue approximation.
Code Information Product code V2920G, Lot ZE8KPMR0, Exp 6/30/2012; Product code PN1695H, Lot ZG8BDZQ0, Exp. 6/30/2012; Product code V2920H, Lot ZG8BJQR0, Exp 6/30/2012; Product code V4731H, Lot ZG8BSSQ0, Exp 6/30/2012; Product code VR214, Lot ZG8BTSD0, Exp. 6/30/2012; Product code W9947, Lot ZG8BHPQ0, Exp 6/30/2012; Product code VR214, Lot ZG9CJXD0, Exp. 6/06/2012; Product code V4851H, Lot ZG8BZWQ0, Exp. 6/30/2012 and  Product code VR426, Lot ZG9BSPE0, Exp. 6/4/2012.
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Christiana Bielinski
908-218-2553
Manufacturer Reason
for Recall		 Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product.
FDA Determined
Cause 2		 Packaging
Action Letters were sent to distributors, Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Room on August 11, 2008, requesting that all affected lot numbers of Vicryl Rapide be discontinued immediately from sale and/or use. A separate correspondence was sent to hospitals. Letters to Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Rooms were advised of the recall and asked to discontinue use of any of the affected lot codes of sutures. Return and credit instructions were provided to the Director of Material Management. Contact Ethicon, Inc. at 1-908-218-2553 for assistance.
Quantity in Commerce 6912
Distribution Worldwide: US and Canada OUS: Australia, New Zealand and Indonesia.
Total Product Life Cycle TPLC Device Report
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 = GAM and Original Applicant = ETHICON, INC.
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