Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Recall
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter		see related information
Date Posted February 23, 2011
Recall Number Z-1198-2011
Product Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 8.0 Fr/ 15 cm, C-UDLMY-801J-ABRM-HC-IHI-FST-A, G50821, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part number: C-UDLMY-801J-ABRM-HC-IHI-FST-A, Global part number G50821. Lot numbers: 2243451; 2273789; 2273801; 2282638; 2282642; 2282644; 2282647; 2287304; 2287314; 2289362; 2290118; 2290127; 2294601; 2296238; 2296247; 2307486; 2309426; 2282647X.
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington, Indiana 47404-9120
For Additional Information Contact Rita A. Harden
812-339-2235
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
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 51,4736 total trays
Distribution Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
 
-
-