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U.S. Department of Health and Human Services

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

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 Class 1 Device Recall Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumensee related information
Date Initiated by FirmOctober 04, 2010
Date PostedFebruary 23, 2011
Recall Status1 Terminated 3 on June 21, 2011
Recall NumberZ-1127-2011
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 Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/15 cm, C-UDLMY-401J- LSC-ABRM-HC-FST, G43994, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part Number: C-UDLMY-401J-LSC- ABRM-HC-FST; Global Part Number G43994, lots F2319920, F2326431, F2326432, F2333044, F2341758, F2343601, F2343602, F2344571, F2352776, F2354568, F2363767, F2364946, F2369649, F2372051, F2380048, F2380790 and F2384349.   
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 kits/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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