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U.S. Department of Health and Human Services

Class 2 Device Recall Prolene Mesh

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  Class 2 Device Recall Prolene Mesh see related information
Date Initiated by Firm November 03, 2003
Date Posted December 18, 2003
Recall Status1 Terminated 3 on November 18, 2008
Recall Number Z-0243-04
Recall Event ID 27654
Product Classification Mesh, Surgical, Polymeric - Product Code FTL
Product Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876
Code Information Catalog number PMII, lot numbers RBE609, expiration date 1/07, and RJJ130, expiration date 7/07  Note: any box with an orange dot on the end of the box is suspected counterfeit product, regardless of lot number.
Recalling Firm/
Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Cardinal Health Quality Systems
Manufacturer Reason
for Recall
Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.
FDA Determined
Cause 2
Action Cardinal Health notified all of their hospital accounts who ordered catalog PMII by letter dated 11/3/03, alerting them to the two lots identifed as counterfeit and requesting the accounts to place all lots on hold in quarantine until further instructions are received. The accounts were requested to call Cardinal Health Customer Service at 800-964-5227 to arrange for product replacement. Cardinal Health customers were sent a follow-up letter dated 11/11/03 with product disposition information, instructing them to return all products bearing lot numbers RBE609 and RJJ130 and all boxes of Prolene with orange dots on the end of the box to Cardinal Health, and to closely examine any remaining boxes to the labeling posted on Ethicon''s website www.Ethicon.com.
Quantity in Commerce 365 boxes
Distribution Nationwide
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.