| | Class 1 Recall
Cook Central Venous Catheter Tray, Double Lumen Polyurethane |  |
| Date Posted |
February 23, 2011 |
| Recall Number |
Z-1100-2011 |
| Product |
Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/12cm, C-UDLMY-401J-RSC-CCT, G26932, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. |
| Code Information |
Part Number: C-UDLMY-401J-RSC-CCT; Global Part Number G26932;
Lots: F2322847, F2328196, F2341763, F2349570, F2359449, F2365678, F2366174, F2366175, F2366176, F2367620, F2368180, F2368181, F2368836, F2369650, F2369814, F2369815 and F2370815
|
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
|
| 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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