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.
Reported: October 12, 2016 Initiated: September 8, 2016 #Z-0051-2017
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
Details
- Recalling Firm
- Argon Medical Devices, Inc
- Units Affected
- 200 units
- Distribution
- Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
- Location
- Athens, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Argon Medical Devices, Inc. Units affected: 200 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 12, 2016. Severity: Moderate. Recall number: Z-0051-2017.
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