—#97204

Product

Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter 7.0 Fr/ 15cm, C-UTLMY-701J-ABRM-HC-FST-A-RD, G44126, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K081113
Affected lot / code info: Part number: C-UTLMY-701J-ABRM-HC-FST-A-RD, Global part number G44126 Lot number: 2241830, 2241946, 2241947, 2244225, 2244835, 2244836, 2244837, 2244839, 2245830, 2253342, 2255605, 2255607, 2255738, 2255739, 2266266, 2267178, 2267969, 2268001, 2275493, 2276215, 2276880, 2276913, 2282406, 2282407, 2282422, 2282423, 2301416, 2301420, 2302127, 2304966, 2305905, 2307487, 2309428, 2313825, 2314047, 2315396, 2315399, 2318757, 2318842, 2321308, 2322431, 2322484, 2325091, 2326801, 2328402, 2328536, 2332350, 2335175, 2336043 and 2282407X

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Cook, Inc.
Address: 750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Timeline

Recall initiated: 2010-10-04
Posted by FDA: 2011-02-23
Terminated: 2011-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97204. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.