—#30283

Product

Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876

FDA product code: FTL — Mesh, Surgical, Polymeric
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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.

Why it was recalled

Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2003-11-03
Posted by FDA: 2003-12-18
Terminated: 2008-11-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30283. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.