Recall Z-0243-04 ยท FTL Mesh, Surgical, Polymeric
Cardinal Health
Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876
| Date | Dec 18, 2003 (initiated Nov 3, 2003) |
| Status | Terminated |
| Reason | Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII. |
| Root cause | Other |
| 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 Prol |
| Quantity | 365 boxes |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.