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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 RAPIDEsee related information
Date Initiated by FirmAugust 11, 2008
Date PostedOctober 02, 2008
Recall Status1 Terminated 3 on June 05, 2012
Recall NumberZ-0021-2009
Recall Event ID 49435
510(K)NumberK033746 K944110 K962480 
Product Classification Suture - Product Code GAM
ProductVICRYL 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 ContactChristiana 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
ActionLetters 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 Commerce6912
DistributionWorldwide: US and Canada OUS: Australia, New Zealand and Indonesia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GAM
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