| | Class 1 Recall
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen |  |
| Date Posted |
February 23, 2011 |
| Recall Number |
Z-1128-2011 |
| Product |
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr12cm, C-UDLMY-501J- RSC-ABRM-HC-FST, G44003, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. |
| Code Information |
Part Number: C-UDLMY-501J-RSC- ABRM-HC-FST; Global Part Number G44003 lots 2238143, 2239207, 2240537, 2241784, 2252487, 2257544, 2267174, 2267995, 2273799, 2275424, 2276829, 2282636, 2286935, 2287725, 2290145, 2302073, 2311589, 2321689 and 2282636X.
|
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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