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.
FDA Recall Z-1029-2016 · Posted 2016-03-01
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Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDRE
Date Initiated2016-02-17
Date Terminated2017-03-08
Product Quantity2000 units
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.
Firm Action
On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.
Root Cause
Process control
Distribution Pattern
Distributed in IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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