Recall Z-0051-2017 ยท DYB Introducer, Catheter
Argon Medical Devices, Inc
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.
| Date | Oct 7, 2016 (initiated Sep 8, 2016) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 200 units |
| Distribution | Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071574 | STIFFER COAXIAL MICRO-INTRODUCER KIT Enpath Medical, Inc., Jul 5, 2007 |