Recall Z-1029-2016 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Argon Medical Devices, Inc
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.
| Date | Mar 1, 2016 (initiated Feb 17, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | On February 17, a letter was sent to Medtronic notifying them of a voluntary recall. |
| Quantity | 2000 units |
| Distribution | Distributed in IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780126 | DILATOR, VESSEL & INTRODUCER, SHEATH Argon Medical Corp., Mar 2, 1978 |