| Class 2 Device Recall VICRYL RAPIDE |  |
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 K944110 K962480 |
Product Classification |
Suture - Product Code GAM
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GAM
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