Kimberly-Clark Radiofrequency Cannula Recalled for Incorrect Active Tip Length
Kimberly-Clark is recalling Radiofrequency Cannulas where the active tip may be 5mm instead of the labeled 10mm, potentially affecting lesion creation in nervous tissue.
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, which is a moderate severity. The hazard involves a manufacturing discrepancy in tip length that may affect procedure efficacy, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Kimberly-Clark Corporation is recalling 550 units of RadiOpaque Radiofrequency Cannulas (Gauge 22, Length 100 mm, Product code PMF22-100-10). The recall involves lots M3085K301 and M2327K301. These medical devices are used to create lesions in nervous tissue when used with a radiofrequency generator and probes.
The recall was initiated because the product may contain a cannula with an active tip length of only 5mm, rather than the 10mm indicated on the label. This discrepancy could affect the intended medical procedure.
The affected units were distributed in the United States in the states of Arizona, California, Delaware, Florida, Louisiana, Maryland, Massachusetts, New Jersey, New York, Ohio, Pennsylvania, and Texas. Healthcare providers and facilities should stop using the affected lots and contact Kimberly-Clark for further instructions.
The recalled product
- Product
- Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator…
- Manufacturer
- Kimberly-Clark Corporation
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)
- Lot M3085K301 and M2327K301
Distribution
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