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U.S. Department of Health and Human Services

Class 3 Device Recall VasoSeal ES

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  Class 3 Device Recall VasoSeal ES see related information
Date Initiated by Firm July 28, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 06, 2004
Recall Number Z-0762-04
Recall Event ID 28389
PMA Number P920004 
Product Classification Device, Hemostasis, Vascular - Product Code MGB
Product 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.
Code Information Lot No. 0605374, Exp. Date May 2005.
Recalling Firm/
Manufacturer		 Datascope Collagen Products Division
1300 MacArthur Blvd.
Mahwah NJ 07430-0605
For Additional Information Contact Gina M. Crossetta
201-995-8783
Manufacturer Reason
for Recall		 Kits are missing the temporary arteriotomy locator (TAL) from the blister package.
FDA Determined
Cause 2		 Other
Action 'Urgent Customer Advisory' Letter dated July 28, 2003.
Quantity in Commerce 1485 kits
Distribution The device was distributed throughout the US to 101 direct accounts. There was one distributor. There was one government account.
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.
PMA Database PMAs with Product Code = MGB and Original Applicant = St. Jude Medical, Inc.
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