CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report

Skater Introducer Set 6F recalled by Argon Medical Devices

Argon Medical Devices is recalling Skater Introducer Set 6F. The recall was initiated on 26 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF /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

Quantity recalled15,795 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2109-2020
FDA event ID: 85562
Recalling firm: Argon Medical Devices, Athens, TX
Classification: Class II
Status: Terminated
Recall initiated: 26 Apr 2020
FDA classified: 22 May 2020
Reported: 3 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

26 Apr 2020	Recall initiated by company
22 May 2020	Classified by FDA	+26 days
3 Jun 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

International distribution to the countries of China, Taiwan.

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

International distribution to the countries of China, Taiwan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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