CLASS II Device recall · Reported 1 Jan 2020 · FDA Enforcement Report
Classic Radiofrequency Cannula - Curved, SMK Compatible Electrode recalled
Abbott Medical is recalling Classic Radiofrequency Cannula - Curved, SMK Compatible Electrode, distributed nationwide in the US. The recall was initiated on 11 Nov 2019 and the FDA has classified it as Class II.
Check your package
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-0720-2020
- FDA event ID
- 84295
- Recalling firm
- Abbott Medical, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Nov 2019
- FDA classified
- 20 Dec 2019
- Reported
- 1 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Nov 2019 | Recall initiated by company | |
| 20 Dec 2019 | Classified by FDA | +39 days |
| 1 Jan 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
A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and country of Bermuda.
Questions about this recall
Why was it recalled?
A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
Which lots are affected?
UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795
Where was it sold?
Worldwide distribution - US Nationwide and country of Bermuda.
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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