| | Class 1 Recall
Central Venous Tray, Triple Lumen Polyurethane |  |
| Date Posted |
February 23, 2011 |
| Recall Number |
Z-1185-2011 |
| Product |
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
5.0 Fr/ 9 cm, UPICDSY-5.0-CT-OTW, G49170, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. |
| Code Information |
Part number: C-UPICDSY-5.0-CT-OTW,
Global part number G49170;
Lot numbers: 2242381, 2250288, 2252456, 2255188, 2259981, 2269809
2276836, 2279174, 2282649, 2285530, 2300174, 2305907, 2314025, 2319587 and 2328553.
|
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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