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Terminated

Tri-State Centurion Sutureless Multi-Lumen CVC Insertion Kit, sterile, 5 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder ECVC175.

FDA Recall Z-1168-2009 · Posted 2009-03-25

Recalling FirmTri-State Hospital Supply Corporation
Recall StatusTerminated
Product CodeLRS
Date Initiated2009-01-14
Date Terminated2009-12-31
Product Quantity10

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.

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