Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876
FDA Recall Z-0243-04 · Posted 2003-12-18
Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeFTL
Date Initiated2003-11-03
Date Terminated2008-11-18
Product Quantity365 boxes
Reason for Recall
Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.