—#97264

Product

Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20 cm Power Injectable, C-UTLMY-701J-RSC-ABRM-HC-IHI-FST-RD, G49805, 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-RSC-ABRM-HC-IHI-FST-RD, Global part number G49805. Lot numbers: 2289360; 2289361; 2289372; 2290112; 2294047; 2295470; 2295472; 2296081; 2296082; 2296096; 2297812; 2297813; 2297819; 2299200; 2300032; 2300736; 2301421; 2308256; 2308260; 2308355; 2311600; 2313815; 2317364; 2318712; 2318746; 2324271; 2326794; 2328390; 2328392; 2328397; 2328544; 232979; 2330540; 2330572; 2335187.

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 #97264. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.