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Argon Medical Devices, Inc recalls ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2
Recalled March 9, 2016 · FDA recall Z-1029-2016 · Argon Medical Devices
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. · FDA Class II
Units
2000 units
Sold at
Distributed in IL.
Description
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.
Product
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.
Manufacturer(s)
Argon Medical Devices, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →