PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton
FDA Recall Z-0249-04 · Posted 2004-07-20
Recalling FirmMcKesson General Medical Corporation
Recall StatusTerminated
Product CodeFTL
Date Initiated2003-10-31
Date Terminated2011-08-04
Product Quantity180 cartons
Reason for Recall
Counterfeit product is an unapproved medical device with associated potential health hazard.
Firm 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.
Root Cause
Other
Distribution Pattern
Counterfeit and authentic product had been shipped to 221 hospitals and surgery centers in the continental US.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.