Recall Z-2109-2020 ยท GCB Needle, Catheter
Argon Medical Devices, Inc
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.
| Date | Apr 26, 2020 |
| Status | Terminated |
| Reason | Tungsten coils of the guidewire included in the introducer kit were detaching. |
| Root cause | Under Investigation by firm |
| Action | On 04/26/2020, the recalling firm sent Urgent Medical Device Recall letter by email to the affected customer/hospital/distributor. The letter will identify the product, the problem, and the action to be taken by the recipient (customer). |
| Quantity | 15,795 units |
| Distribution | International distribution to the countries of China, Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.