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.
This recall has been terminated (originally issued March 1, 2016).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- February 17, 2016
- Posted
- March 1, 2016
- Terminated
- March 8, 2017
- Recall Number
- Z-1029-2016
- Quantity
- 2000 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distributed in IL.
Lot / Code Info
Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)
Root Cause
Process control
Action Taken
On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.
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