Z-2109-2020Class II

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

Name: Z-2109-2020 Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 -
Creator: Argon Medical Devices, Inc
Published: 2020-04-26
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2020-04-26 / Terminated

FDA source

Argon Medical Devices, Inc began a recall of Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with... on 2020-04-26. FDA classified it as Class II and gives the reason as "Tungsten coils of the guidewire included in the introducer kit were detaching". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2109-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-26
Posted: 2020-05-22
Terminated: 2022-12-16
Recalling firm: Argon Medical Devices, Inc
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.
Product code: GCB Needle, Catheter
Reason for recall: Tungsten coils of the guidewire included in the introducer kit were detaching.
FDA root cause: Under Investigation by firm
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).
Quantity in commerce: 15,795 units
Distribution: International distribution to the countries of China, Taiwan.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2109-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2109-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-22

Product code GCB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)