| | Class 1 Recall
Spectrum Central Venous CatheterTray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, |  |
| Date Posted |
February 23, 2011 |
| Recall Number |
Z-1155-2011 |
| Product |
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 7.0 Fr/ 15cm, C-UTLMY-701J-190-PIG-ABRM-FST-A-RD, G47845, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. |
| Code Information |
Part number: C-UTLMY-701J-190-PIG-ABRM-FST-A-RD, Global part number G47845;
Lot numbers: 2236494; 2240335; 2241865; 2243454; 2243479; 2247700; 2248271; 2248942; 2251989; 2253341; 2255612; 2255615; 2259340; 2266271; 2268000; 2269799; 2275491; 2277906; 2282472; 2286322; 2286941; 2291779; 2293489; 2296811; 2299444; 2303166; 2307478; 2311592; 2315327; 2318744; 2318841; 2329793; 2334332
|
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 trays |
| Distribution |
Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia. |
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