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.
This recall has been terminated (originally issued April 26, 2020).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- April 26, 2020
- Terminated
- December 16, 2022
- Recall Number
- Z-2109-2020
- Quantity
- 15,795 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Tungsten coils of the guidewire included in the introducer kit were detaching.
Distribution
International distribution to the countries of China, Taiwan.
Lot / Code Info
REF /LOT: 651506300/ 11267865, 11271397, 11277305, 11287825, 11293349, 11288772, 11290387, 11263199, 11262264, 11258778, 11254942, 11253443 REF/ LOT: 655506300 / 11268009, 11284776, 11266592, 11285976, 11287826, 11280359, 11260512, 11252843, 11248583, 11277295
Root Cause
Under Investigation by firm
Action Taken
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).