—#97211

Product

Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMY-701J-LSC-ABRM-HC-FST-RD, G47832, 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-LSC-ABRM-HC-FST-RD, Global part number G47832 Lot number: 2227805, 2231998, 2233817, 2235524, 2235535, 2240333, 2240347, 2241835, 2244218, 2246770, 2247661, 2247664, 2247966, 2247967, 2247968, 2247969, 2253276, 2253302, 2255617, 2255743, 2259343, 2259344, 2268076, 2268927, 2269801, 2275440, 2276221, 2277892, 2278671, 2280762, 2282534, 2282648, 2282656, 2282660, 2285513, 2285517, 2285526, 2295485, 2299455, 2302128, 2308273, 2309356, 2311576, 2315347, 2317454, 2325084, 2326692, 2327493and 2332352.

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 #97211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.