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U.S. Department of Health and Human Services

Class 2 Device Recall ThromCat

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  Class 2 Device Recall ThromCat see related information
Date Initiated by Firm February 07, 2007
Date Posted March 08, 2007
Recall Status1 Terminated 3 on June 12, 2007
Recall Number Z-0597-2007
Recall Event ID 37393
510(K)Number K060016  
Product Classification Thrombectomy Catheter - Product Code MCW
Product ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.
Code Information Lot number 54877 exp December 2007, Lot number 55318 exp January 2008, Lot number 55218 exp January 2008, and Lot number 54821 exp December 2007
Recalling Firm/
Manufacturer		 Kensey Nash Corp
735 Pennsylvania Dr
Exton PA 19341-1130
For Additional Information Contact Robin M. Fatzinger
484-713-2100
Manufacturer Reason
for Recall		 Face seal may wear excessively and cause particulate matter.
FDA Determined
Cause 2		 Other
Action On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product.
Quantity in Commerce 165 units
Distribution Nationwide.
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.
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