InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
FDA Recall Z-1439-2010 · Posted 2010-04-28
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Recalling FirmIntervascular S.A.S.
Recall StatusTerminated
Product CodeDSY
Date Initiated2009-12-09
Date Terminated2010-04-29
Product Quantity5
Reason for Recall
The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.
Firm 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.
Root Cause
Other
Distribution Pattern
US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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