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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 Recall
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen
see related information
Date Posted February 23, 2011
Recall Status1 Terminated on June 21, 2011
Recall Number Z-1125-2011
Recall Event ID 57663
Premarket Notification
510(K) Number
K081113 
Product Classification Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days - Product Code FOZ
Product Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/5 cm, C-UDLMY-401J- PED-ABRM-HC-FST, G43992, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part Number: C-UDLMY-401J-PED- ABRM-HC-FST; Global Part Number G43992, lots 2227693, 2239036, 2241246, 2243904, 2246221, 2248312, 2254310, 2256092, 2256098, 2258323, 2264568, 2267967, 2270680, 2275430, 2275449, 2276888, 2280759, 2282646, 2282655, 2284659, 2284706, 2294745, 2299209, 2300746, 2302090, 2305911, 2312984 2315418, 2318765, 2321684, 2328529 and 2335168.
Recalling Firm/
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington, Indiana 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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = COOK, INC.
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