| | Class 1 Recall
Spectrum Soft Central Venous Catheter Tray Minocyciine/Rifampin Antibiotic Impregnated |  |
| Date Posted |
February 23, 2011 |
| Recall Number |
Z-1106-2011 |
| Product |
Spectrum Soft Central Venous Catheter Tray Minocyciine/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 4.0Fr/8cm, C®SDLMY ®401 J®ABRM®FST, G29413, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. |
| Code Information |
Part Number: C¿SDLMY ¿401 J¿ABRM¿FST; Global Part Number G29413;
Lots: 2228497, 2228500, 2236164, 2241967, 2251148, 2252533, 2256877, 2275432, 2294027, 2312977, 2317385, 2326672 and 2328409.
|
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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