Class 1 Device Recall Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen

• Date Initiated by Firm: October 04, 2010
• Date Posted: February 23, 2011
• Recall Status: Terminated on June 21, 2011
• Recall Number: Z-1147-2011
• Recall Event ID: 57663
• 510(K)Number: K081113
• Product Classification: Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
• Product: Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, C-UTLMY-701J-RSC-ABRM-HC-FST-A-RD, G44128, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
• Code Information: Part number: C-UTLMY-701J--RSC--ABRM-HC-FST-A-RD, Global part number G44128 Lot number: 2231979, 2231980, 2231999, 2238977, 2238978, 2238979, 2238980, 2238981, 2238982, 2243443, 2244830, 2244831, 2244832, 2245780, 2245781, 2246223, 2246583, 2246584, 2246585, 2246586, 2246587, 2246588, 2246589, 2246590, 2246744, 2246745, 2246746, 2246747, 2246756, 2246757, 2246758, 2246759, 2246801, 2246802, 2246803, 2246804, 2246805, 2246806, 2246807, 2246808, 2246819, 2246820, 2246821, 2246822, 2246823, 2246824, 2246825, 2247317, 2247318, 2247669, 2247670, 2249285, 2249286, 2249287, 2249288, 2249289, 2250281, 2250282, 2252448, 2254304, 2254305, 2254306, 2254307, 2254308, 2254313, 2254314, 2254315, 2254316, 2267158, 2267159, 2270627, 2270628, 2270629, 2270630, 2273791, 2273792, 2273793, 2273794, 2273795, 2273796, 2276867, 2276868, 2279126, 2279127, 2279128, 2279129, 2279130, 2279131, 2279132, 2280740, 2280741, 2281671, 2281672, 2281674, 2281675, 2281676, 2286376, 2286384, 2286385, 2287302, 2287303, 2289365, 2289366, 2289373, 2289374, 2289375, 2289376, 2289874, 2289875, 2289876, 2289877, 2289878, 2289879, 2289880, 2289881, 2290914, 2300161, 2302129, 2302130, 2303849, 2304971, 2305912, 2307488, 2307489, 2309357, 2309431, 2309432, 2309433, 2312069, 2312070, 2312071, 2312987, 2313826, 2315397, 2315400, 2315401, 2315402, 2317380, 2317391, 2317392, 2317456, 2317457, 2317458, 2318844, 2319573, 2319595, 2320314, 2320315, 2323365, 2323366, 2324256, 2324278, 2324279, 2324280, 2325097, 2326802, 2326803, 2327439, 2327440, 2327494, 2327495, 2327496, 2328415, 2328538, 2328539, 2328540, 2331475, 2332337, 2332353, 2332354, 2332355, 2336045, 2246223X, 2246747X and 2289880X.
• Recalling Firm/ Manufacturer: Cook, Inc.; 750 Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Rita A. Harden; 812-339-2235
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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.
• Quantity in Commerce: 51,473 total kits/trays
• Distribution: Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FOZ and Original Applicant = COOK, INC.