Tri-State Centurion Plastic Laceration Set, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder SUT3390.
FDA Recall Z-1322-2009 · Posted 2009-04-30
Recalling FirmTri-State Hospital Supply Corporation
Recall StatusTerminated
Product CodeMCZ
Date Initiated2009-01-14
Date Terminated2009-12-24
Product Quantity112
Reason for Recall
Compromised sterility, as the package seals may be inadequate.
Firm Action
A letter titled "Urgent Product Recall Notice" was sent by Tri-State Hospital Supply Corporation to all consignees via certified mail titled dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand by sending the Accountability Information Form to the firm via fax (1-517-546-3356) or email and to hold the product for retrieval.
Further questions should be addressed to Tri-State Hospital Supply Corp. at 1-517-546-5400 extension 1135.
Root Cause
Packaging process control
Distribution Pattern
Nationwide including states of NC, FL, TX, NJ, IL, MA, GA and IA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.