Recall Z-1029-2016— Argon Medical Devices, Inc

Name: FDA recall Z-1029-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-17

Class II · Terminated

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2016-02-17, terminated 2017-03-08. It names one FDA 510(k) clearance: K780126. 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.. 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..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-02-17
Terminated: 2017-03-08
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K780126 — DILATOR, VESSEL & INTRODUCER, SHEATHArgon Medical Corp.·cleared 1978-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.