• 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 2 Recall
Cook Antimicrobial Catheter
see related information
Date Posted March 16, 2007
Recall Number Z-0637-2007
Product COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum® Glide® Antimicrobial Catheter with EZ--Pass® Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A.
Code Information Lots 1794998 and 1793611.
Recalling Firm/
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington, Indiana 47404-9120
Consumer Instructions Contact the recalling firm for information
Reason for
Recall
These catheters do not include the proximal sidehole as required by the specification.
Action Consignees were notified by phone on 1/2/07 and instructed to return the product.
Quantity in Commerce 100
Distribution Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina.
 
-
-