MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a cathe
FDA device recall Z-0051-2017 · posted 2016-10-07 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- 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
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 200 units
- Distribution
- Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
- Date initiated
- 2016-09-08
- Date posted
- 2016-10-07
- Date terminated
- 2017-06-07
- Location
- Athens, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STIFFER COAXIAL MICRO-INTRODUCER KIT (K071574) | Enpath Medical, Inc. | 2007-07-05 |