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Terminated

Peripherally Inserted Central Venous Catheter Tray Silicone, CPICSY401HOPKINS0911 00, G13169, 4.0 Fr/60cm, Sterile, Cook Incorporated, 750 Daniels Way, Bloomington, IN 47404 , USA

FDA Recall Z-1096-2011 · Posted 2011-02-23

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeLJT
Date Initiated2010-10-04
Date Terminated2011-06-21
Product Quantity51,473 total kits/trays

Reason for Recall

Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. During a routine test for syringe sterility, a possible integrity failure wa

Firm Action

Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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