Recall Z-0597-2007
Kensey Nash Corp · initiated February 7, 2007
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.
Codes / lots: 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
Reason for recall
Face seal may wear excessively and cause particulate matter.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0597-2007
- Initiated
- February 7, 2007
- Posted by FDA
- March 8, 2007
- Terminated
- June 12, 2007
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 165 units
- Distribution
- Nationwide.
- Recalling firm
- Kensey Nash Corp, Exton, PA