| | Class 1 Recall Spectrum Central Venous Catheter Tray Minocyciine/Rifampin Antibiotic Impregnated |  |
| Date Posted |
February 23, 2011 |
| Recall Number |
Z-1111-2011 |
| Product |
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/20cm, C®UDLMY®751J®RSC®ABRM®FST®A, G29518, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. |
| Code Information |
Part Number: C¿UDLMY¿751J¿RSC¿ABRM¿FST¿A; Global Part Number G29518,
Lots: F2317767, F2322852, F2339813, F2343616, F2346299, F2347030, F2354581, F2359452, F2366179, F2378033, F2380795 and F2383261.
|
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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