FDA Recall
Terminated
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
Recall: Z-1439-2010
·
Initiated December 9, 2009
Recall
- Recall Number
- Z-1439-2010
- Event Number
- 54889
- Firm
- Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France
- FEI Number
- 3002707083
- Product Code
- DSY
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 9, 2009
- Posted
- April 28, 2010
- Terminated
- April 29, 2010
Description
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
Reason
The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.
Action
The firm sent recall letters to all customers on December 9, 12009. Calls had been made prior to the letter being sent. Because all product was recovered, no additional questions are anticipated.
Distribution
US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.
Quantity
5