FDA-Device2015-08-19Class II
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
Boston Scientific Corporation
Hazard
AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
Sold states
Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
Affected count
total of 9 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2378-2015Don't want to check this manually?
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