—#97243

Product

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, 5.0 Fr/ 60 cm, UPICDSY-5.0-CT-NT, G49169, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K072625
Affected lot / code info: Part number: C-UPICDSY-5.0-CT-NT, Global part number G49169; Lot numbers: 2244226, 2246219, 2251161, 2255157, 2264598, 2267957, 2267971, 2275435, 2275476, 2278549, 2278570, 2287707, 2287709, 2292788, 2292791, 2298486, 2302064, 2302098, 2306592, 2313790, 2317361, 2317382, 2321273, 2325079, 2327447, 2334833 and 2335156.

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 #97243. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.