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Terminated

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 Recall Z-2109-2020 · Posted None

Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeGCB
Date Initiated2020-04-26
Date Terminated2022-12-16
Product Quantity15,795 units

Reason for Recall

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

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).

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution to the countries of China, Taiwan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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