Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876
This recall has been terminated (originally issued December 18, 2003).
- Company
- Cardinal Health
- Recall Initiated
- November 3, 2003
- Posted
- December 18, 2003
- Terminated
- November 18, 2008
- Recall Number
- Z-0243-04
- Quantity
- 365 boxes
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.
Distribution
Nationwide
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.
Root Cause
Other
Action Taken
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.