| | Class 1 Recall
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen |  |
| Date Posted |
February 23, 2011 |
| Recall Number |
Z-1125-2011 |
| Product |
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/5 cm, C-UDLMY-401J- PED-ABRM-HC-FST, G43992, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. |
| Code Information |
Part Number: C-UDLMY-401J-PED- ABRM-HC-FST; Global Part Number G43992, lots 2227693, 2239036, 2241246, 2243904, 2246221, 2248312, 2254310, 2256092, 2256098, 2258323, 2264568, 2267967, 2270680, 2275430, 2275449, 2276888, 2280759, 2282646, 2282655, 2284659, 2284706, 2294745, 2299209, 2300746, 2302090, 2305911, 2312984
2315418, 2318765, 2321684, 2328529 and 2335168.
|
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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