Abbott Recalls Mislabeled Radiofrequency Cannulas Due to Manufacturing Error
Abbott Medical is recalling 470 radiofrequency cannulas that were incorrectly labeled with a 5mm active tip length instead of 10mm.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error regarding device specifications without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Abbott Medical is recalling 470 units of the CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode (REF C-1005-S). The recall is due to a manufacturing error that resulted in a single lot of cannulas with a 10mm active tip length being labeled as having a 5mm active tip length.
The affected devices are distributed worldwide, including the United States and Bermuda. The specific lot number is 6865795, and the UDI is (01) 05415067028693(17)220131(10) 6865795.
Healthcare providers and consumers should stop using the affected devices and contact Abbott Medical for instructions on return or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Abbott Medical
- Hazard
- Affected units
- 470
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI (01) 05415067028693(17)220131(10) 6865795 lot 6865795
Distribution
Distributed nationwide across the United States.
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