FDA Device recall Z-1029-2016
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 I…
- FDA Device
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of 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 I… by Argon Medical Devices, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1029-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-17 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Argon Medical Devices |
| Distribution | IL |
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.
Identifiers
| code_info | Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Argon Medical Devices
- L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - General Biospy Tray, REF: GUTS1000
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - Arterial Line Kit 20ga x 6, REF: 400115A
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
All Argon Medical Devices recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1029-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.