FDA Recall
Terminated
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.
Recall: Z-2109-2020
·
Initiated April 26, 2020
Recall
- Recall Number
- Z-2109-2020
- Event Number
- 85562
- Firm
- Argon Medical Devices, Inc
- FEI Number
- 1625425
- Product Code
- GCB
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 26, 2020
- Terminated
- December 16, 2022
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002
Description
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.
Reason
Tungsten coils of the guidewire included in the introducer kit were detaching.
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).
Distribution
International distribution to the countries of China, Taiwan.
Quantity
15,795 units