| | Class 1 Recall Central Venous Catheter Tray, Triple Lumen |  |
| Date Posted |
February 23, 2011 |
| Recall Number |
Z-1149-2011 |
| Product |
Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMY-701J-LSC-CCT-RD, G47818, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. |
| Code Information |
Part number: C-UTLMY-701J-LSC-CCT-RD, Global part number G47818
Lot number: F2313884, F2325884, F2328415, F2351905, F2357862 and
F2365096
|
Recalling Firm/ Manufacturer |
Cook, Inc. 750 Daniels Way Bloomington, Indiana 47404-9120 |
| For Additional Information Contact |
Rita A. Harden 812-339-2235
|
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
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| 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. |
| Quantity in Commerce |
51,473 total kits/trays |
| Distribution |
Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia. |
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