—#97210

Product

Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, C-UTLMY-701J-ABRM-HC-FST-RD, G47831, 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-ABRM-HC-FST-RD, Global part number G47831 Lot number: 2238150, 2238157, 2240345, 2241829, 2241831, 2241867, 2241944, 2241945, 2241948, 2245787, 2245831, 2246217, 2247688, 2248272, 2248321, 2248943, 2248944, 2250303, 2251986, 2251998, 2252008, 2253301, 2253343, 2255616, 2255740, 2256110, 2256160, 2256167, 2257546, 2259341, 2259414, 2264558, 2265389, 2265396, 2266276, 2268074, 2268926, 2270316, 2270318, 2270682, 2273807, 2275454, 2275455, 2275469, 2276890, 2277907, 2278555, 2278560, 2278670, 2279209, 2281658, 2281659, 2282539, 2283327, 2283328, 2286942, 2291834, 2291835, 2291836, 2291837, 2291839, 2291840, 2292792, 2292794, 2292797, 2294041, 2294603, 2294707, 2294715, 2294748, 2296188, 2297830, 2299453, 2300861, 2300862, 2303847, 2304440, 2304444, 2304445, 2308280, 2308350, 2309429, 2311575, 2311593, 2312986, 2315329, 2315344, 2315345, 2315938, 2315940, 2315950, 2316754, 2317390, 2317452, 2321297, 2321298, 2323347, 2323353, 2325092, 2326690, 2326710, 2327438, 2328414, 2328537, 2331452, 2331459, 2332351, 2334841, 2335176, 2337152 and 2282539X.

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 #97210. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.