—#97220

Product

Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 5cm, C-UDLMY-401J-PED-ABRM-HC-IHI-FST, G48059, 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-UDLMY-401J-PED-ABRM-HC-IHI-FST, Global part number G48059; Lot numbers: F2350380; F2354570; F2363768; F2367619; F2372052; F2372053; F2377327

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 #97220. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.