Argon Medical Devices, Inc: Medical Device Recall in 2016 - (Recall #: Z-1029-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 17, 2016

Date Posted: March 9, 2016

Recall Number: Z-1029-2016

Event ID: 73376

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.

Status: Terminated

Product Quantity: 2000 units

Code Information:

Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)

Distribution Pattern:

Distributed in IL.

Voluntary or Mandated:

Voluntary: Firm initiated