FDA-Device2016-03-09Class II
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Argon Medical Devices, Inc
Hazard
The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
Sold states
Distributed in IL.
Affected count
2000 units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1029-2016Don't want to check this manually?
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