Recall Z-0249-04 ยท FTL Mesh, Surgical, Polymeric
McKesson General Medical Corporation
PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton
| Date | Jul 20, 2004 (initiated Oct 31, 2003) |
| Status | Terminated |
| Reason | Counterfeit product is an unapproved medical device with associated potential health hazard. |
| Root cause | Other |
| Action | The distributor notified all distribution centers and field personnel by e-mail on 10/29/03. The firm''s centers were instructed to inspect and quarantine lots RBE609 and RJJ130. Field personnel were instructed to notify customers to quarantine counterfeit product and any suspect product. On 10/30/03, the recalling distributor notified its field representatives to inspect and quarantine all lots of the mesh. The firm issued a recall notification with reply form to all consignees receiving surgical mesh product since Jan 03. |
| Quantity | 180 cartons |
| Distribution | Counterfeit and authentic product had been shipped to 221 hospitals and surgery centers in the continental US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.