PlainRecalls
FDA Devices Moderate Class II Terminated

CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

Reported: January 1, 2020 Initiated: November 11, 2019 #Z-0720-2020

Product Description

CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

Reason for Recall

A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.

Details

Recalling Firm
Abbott Medical
Units Affected
470 devices
Distribution
Worldwide distribution - US Nationwide and country of Bermuda.
Location
Plymouth, MN

Frequently Asked Questions

What product was recalled?
CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.. Recalled by Abbott Medical. Units affected: 470 devices.
Why was this product recalled?
A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 1, 2020. Severity: Moderate. Recall number: Z-0720-2020.