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Terminated

VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. The device is indicated for use in sealing the femoral arterial puncture site.

FDA Recall Z-0762-04 · Posted 2004-07-20

Recalling FirmDatascope Collagen Products Division
Recall StatusTerminated
Product CodeMGB
Date Initiated2003-07-28
Date Terminated2004-04-06
Product Quantity1485 kits

Reason for Recall

Kits are missing the temporary arteriotomy locator (TAL) from the blister package.

Firm Action

'Urgent Customer Advisory' Letter dated July 28, 2003.

Root Cause

Other

Distribution Pattern

The device was distributed throughout the US to 101 direct accounts. There was one distributor. There was one government account.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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