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

Class 2 Device Recall ThromCat Thrombectomy Catheter System Catalog number 6300001.

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


New Search Back to Search Results
  Class 2 Device Recall ThromCat Thrombectomy Catheter System Catalog number 6300001. see related information
Date Initiated by Firm May 21, 2007
Date Posted July 23, 2007
Recall Status1 Terminated 3 on August 29, 2007
Recall Number Z-1115-2007
Recall Event ID 38055
510(K)Number K060016  
Product Classification Thrombectomy Catheter - Product Code MCW
Product ThromCat Thrombectomy Catheter System. Catalog number 63000-01
Code Information Catalog number 63000-01, Lot number 57292 exp March 2008
Recalling Firm/
Manufacturer		 Kensey Nash Corp
735 Pennsylvania Dr
Exton PA 19341-1130
For Additional Information Contact Robin M. Fatzinger
484-713-2100 Ext. 2146
Manufacturer Reason
for Recall		 Defective component (power supply)
FDA Determined
Cause 2		 Other
Action New power supplies were sent directly to Sales Representatives who personally replaced the defective power supplies and returned them to Kensey Nash. A voice mail to all affected KNC Sales Representatives went out on 5/21/07 instructing them to contact the affected accounts immediately.
Quantity in Commerce 11 units
Distribution Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MCW and Original Applicant = KENSEY NASH CORP.
-
-