—#97100

Product

Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/12cm, C-UDLMY-401J-RSC-CCT, G26932, 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-RSC-CCT; Global Part Number G26932; Lots: F2322847, F2328196, F2341763, F2349570, F2359449, F2365678, F2366174, F2366175, F2366176, F2367620, F2368180, F2368181, F2368836, F2369650, F2369814, F2369815 and F2370815

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 #97100. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.