—#181283

Product

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.

FDA product code: GCB — Needle, Catheter
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected 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

Why it was recalled

Tungsten coils of the guidewire included in the introducer kit were detaching.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

Distribution pattern: International distribution to the countries of China, Taiwan.

Timeline

Recall initiated: 2020-04-26
Terminated: 2022-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181283. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.