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U.S. Department of Health and Human Services

Class 1 Device Recall Spectrum Central Venous CatheterTray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane,

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 Class 1 Device Recall Spectrum Central Venous CatheterTray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane,see related information
Date Initiated by FirmOctober 04, 2010
Date PostedFebruary 23, 2011
Recall Status1 Terminated 3 on June 21, 2011
Recall NumberZ-1155-2011
Recall Event ID 57663
510(K)NumberK081113 
Product Classification Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
ProductSpectrum Central Venous Catheter Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 7.0 Fr/ 15cm, C-UTLMY-701J-190-PIG-ABRM-FST-A-RD, G47845, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part number: C-UTLMY-701J-190-PIG-ABRM-FST-A-RD, Global part number G47845;   Lot numbers: 2236494; 2240335; 2241865; 2243454; 2243479; 2247700; 2248271; 2248942; 2251989; 2253341; 2255612; 2255615; 2259340; 2266271; 2268000; 2269799; 2275491; 2277906; 2282472; 2286322; 2286941; 2291779; 2293489; 2296811; 2299444; 2303166; 2307478; 2311592; 2315327; 2318744; 2318841; 2329793; 2334332
Recalling Firm/
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactRita 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 2
Nonconforming Material/Component
ActionCook, 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 Commerce51,473 total trays
DistributionWorldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FOZ
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