FDAClass IIOctober 12, 2016

MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi recall

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…

Why was MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

11149662, 11151447, 11151617, and 11149822.

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…
Recalling firm
Argon Medical Devices, Inc
Quantity
200 units
Distribution
Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
Recall date
October 12, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls