Tri-State Centurion Umbilical Vessel Tray without catheter, sterile, 5 per tray, Tri-State Supply Corporation, Howell, MI.; reorder UVT 170.
FDA Recall Z-1169-2009 · Posted 2009-03-25
Advertisement
Recalling FirmTri-State Hospital Supply Corporation
Recall StatusTerminated
Product CodeKGZ
Date Initiated2009-01-14
Date Terminated2009-12-31
Product Quantity15
Reason for Recall
Lack of assurance of sterility, as the package seals may be inadequate.
Firm Action
Tri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.
Root Cause
Packaging process control
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement