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Recall Observatory FDA recall evidence

Device 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.

Z-1029-2016

February 17, 2016

Class II

Product summary

Firm
Argon Medical Devices, Inc
Event
Event 73376
Status
Terminated
Classification
Class II
Quantity
2000 units
Official record key
device-enforcement:Z-1029-2016

Official wording

Reason: 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.

Code information: Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)

Distribution pattern: Distributed in IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.