—#149676

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.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K071574
Affected lot / code info: 11149662, 11151447, 11151617, and 11149822.

Why it was 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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

Distribution pattern: Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.

Timeline

Recall initiated: 2016-09-08
Posted by FDA: 2016-10-07
Terminated: 2017-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149676. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.