Recall Z-0051-2017— Argon Medical Devices, Inc
Class II · Terminated
Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2016-09-08, terminated 2017-06-07. It names one FDA 510(k) clearance: K071574. Product: MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.. Reason: The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath.
- Recalling firm
- Argon Medical Devices, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-08
- Terminated
- 2017-06-07
- Firm location
- Athens, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
Reason for recall
The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
Data sourced from openFDA. This site is unofficial and independent of the FDA.