FDA-Device2022-05-04Class II
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Freudenberg Medical, Llc
Hazard
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Sold states
US distribution: GA, OH Foreign distribution: Netherlands
Affected count
8 units (OUS)
Manufactured in
2301 Centennial Blvd, Jeffersonville, IN, United States
Products
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2022Don't want to check this manually?
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