Device recall: Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage…

Class II FDA enforcement event 85562. Recall start date: 26 Apr 2020. Status in the FDA record: Terminated. Termination date: 16 Dec 2022.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Argon Medical Devices, Inc started this device recall on 26 Apr 2020. The firm address in the FDA record is in Athens, TX. FDA put the recall in Class II. FDA event 85562 has 1 product record. The first FDA enforcement report date is 3 Jun 2020. The record gives the status Terminated, with the termination date 16 Dec 2022.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

International distribution to the countries of China, Taiwan.

Recalling firm

Argon Medical Devices, Inc, Athens, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 85562: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2109-2020	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.	15,795 units	Class II	Terminated	3 Jun 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 23

Other events of the firm

Other FDA enforcement events of Argon Medical Devices, Inc
Initiated	Product (first record)	Type	Class	Records
15 Jun 2026	L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60c	Device	Class II	2
1 Jun 2026	Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A	Device	Class I	6
12 Sep 2025	Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for	Device	Class II	1
2 Jul 2024	BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 3	Device	Class II	1
14 Jun 2024	L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539	Device	Class II	1
8 Jun 2023	Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Deliver	Device	Class II	1
24 Jan 2022	1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"	Device	Class II	1
4 Oct 2021	SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE B	Device	Class II	1
8 Jul 2021	Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool	Device	Class II	1
10 Dec 2020	Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introd	Device	Class II	6

Argon Medical Devices, Inc: all 23 events

Official channels

FDA enforcement report Z-2109-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 85562. https://recallregister.com/fda/ii/85562/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: International distribution to the countries of China, Taiwan.
What quantity of product is in FDA event 85562?: The FDA record gives this quantity: 15,795 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.