Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed. Intended use: Soft Tissue app

FDA device recall Z-1608-2010 · posted 2010-05-18 · Terminated

Recall details

Recalling firm

Ethicon, Inc.

Reason for recall

Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe.

Action taken

"Expansion of 2008 Voluntary Recall" notification letters dated April 20, 2010 were sent by second day UPS to customers, distributors, Materials Managers, Director of Surgical Services, and Directors of Risk Management. The letters state that the expansion includes 37 lots of products. The letters describe the product, problem and action t to be taken by customers. The customers were instructed to immediately discontinue use of any of the affected product and to remove from all inventory and returned to Stericycle. If they are not returning product, they should mail the enclosed business reply card to Stericycle. The customers should notify their end customers of this recall. If their end customers have the affected product they should first call 1-888-345-0483 to get appropriate shipping labels. THIS RECALL EXPANSION ONLY IMPACTS THE VICRYL RAPID SUTURE. THIS DOES NOT INCLUDE THE VICRYL* ADN VICRYL* PLUS PRODUCTS. Please don't hesitate to contact Christie Bielinski directly at 908-218-2553 or via email at cbielinsi@its.jnj.com should you have any questions or require additional information.

Root cause

Other

Status

Terminated

Product code

GAM

Quantity affected

118332 eaches were sent to the US Distribution Center, of which 69936 eaches were shipped to primary consignees.

Distribution

Worldwide distribution: USA and Austria, Belgium, Canada, Chile, China, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Malaysia, Middle East, Netherlands Anti

Date initiated

2010-04-20

Date posted

2010-05-18

Date terminated

2011-07-19

Location

Somerville, NJ

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