Recall Z-1124-2011 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cook, Inc.
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/8 cm, C-UDLMY-401J- ABRM-HC-FST, G43991, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
| Date | Feb 23, 2011 (initiated Oct 4, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| 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 | 51,473 total kits/trays |
| Distribution | Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081113 | COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS Cook, Inc., Jul 30, 2008 |