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Class 1 Device Recall Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter |
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Date Initiated by Firm |
October 04, 2010 |
Date Posted |
February 23, 2011 |
Recall Status1 |
Terminated 3 on June 21, 2011 |
Recall Number |
Z-1196-2011 |
Recall Event ID |
57663 |
510(K)Number |
K081113
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Product Classification |
Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
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Product |
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm, C-UDLMY-801J-ABRM-HC-FST-A, G50819, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. |
Code Information |
Part number: C-UDLMY-801J-ABRM-HC-FST-A, Global part number G50819. Lot numbers: 2219452; 2227560; 2238972; 2239033; 2239051; 2270311; 2287706; 2291833; 2301411; 2307458; 2315398. |
Recalling Firm/ Manufacturer |
Cook, Inc. 750 Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact |
Rita A. Harden 812-339-2235
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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
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FDA Determined Cause 2 |
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 trays |
Distribution |
Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FOZ and Original Applicant = COOK, INC.
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