Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 12cm, C-UDLMY-401J-RSC-ABRM-HC-IHI-FST, G48061, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall Z-1162-2011 · Posted 2011-02-23
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Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeFOZ
Date Initiated2010-10-04
Date Terminated2011-06-21
Product Quantity51,473 total 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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