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.
This recall has been terminated (originally issued October 7, 2016).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- September 8, 2016
- Posted
- October 7, 2016
- Terminated
- June 7, 2017
- Recall Number
- Z-0051-2017
- Quantity
- 200 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
Lot / Code Info
11149662, 11151447, 11151617, and 11149822.
Root Cause
Nonconforming Material/Component
Action Taken
An Urgent - Product Recall Notice was sent to consignees identifying the affected device and the reason for the recall. Customers were asked to return all affected devices. The firm will send replacement devices upon receipt of the returned affected product and once assembly of a cleared lot that does not contain recalled devices has been completed. If there are questions regarding the letter or recall action, customers can contact Beckie.Ellis@argonmedical.com.