VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. Ethicon, Inc., a Johnson &

FDA device recall Z-0021-2009 · posted 2008-10-02 · Terminated

Recall details

Recalling firm

Ethicon, Inc.

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.

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

GAM

Quantity affected

6912

Distribution

Worldwide: US and Canada OUS: Australia, New Zealand and Indonesia.

Date initiated

2008-08-11

Date posted

2008-10-02

Date terminated

2012-06-05

Location

Somerville, NJ

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