Northgate Electrohydraulic Lithotripter Probe Recalled for Incorrect Labeling
Northgate Technologies is recalling 186 electrohydraulic lithotripter probes due to incorrect reference numbers on labels, which could delay patient care.
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 source text identifies the hazard as a labeling error that could delay care, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
Plain-English summary
Northgate Technologies, Inc. is recalling 186 units of the Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS. The recall was initiated because the inner and outer labels on the product contain an incorrect reference number, 9-202-3751DS, instead of the correct model number.
The affected probes are used with a Model 9-201-00 Autolith lithotripter for electrohydraulic lithotripsy, a method used to fragment and remove large stones. According to Northgate Technologies, the resistor in the probe prevents the mislabeled product from being used with the incorrect generator. The company notes that the labeling error could delay care.
The recalled units were distributed in the United States to Massachusetts, Nebraska, and Tennessee, as well as internationally to Canada. Consumers and healthcare providers should stop using the affected probes and contact Northgate Technologies for further instructions.
The recalled product
- Product
- Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
- Manufacturer
- Northgate Technologies, Inc.
- Hazard
- Affected units
- 186
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 (2)
- Model No. 9-195-371DS
- Lot/Serial Number LDS12516
Distribution
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