Biliary Electrohydraulic Lithotripter Probe Recalled for Incorrect Product Labeling
Northgate Technologies is recalling 55 AUTOLITH Touch 1.9F biliary lithotripter probes due to incorrect product labeling. Affected devices were distributed nationwide in Massachusetts.
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: Class II FDA recall for product labeling inaccuracy with no reported illnesses or injuries. Labeling errors without evidence of actual harm are classified as moderate per the rubric.
Plain-English summary
Northgate Technologies, Inc. is recalling 55 AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probes because the product labeling is incorrect. The affected devices carry lot code BSC15876 and were distributed nationwide in Massachusetts.
The company determined that the product labeling contains inaccuracies. Healthcare providers with these devices should contact Northgate Technologies, Inc. for guidance on replacement or return of the affected units.
The recalled product
- Product
- AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
- Manufacturer
- Northgate Technologies, Inc.
- Hazard
- Affected units
- 55
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 (3)
- NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620
- Lot code: BSC15876
- GTIN: 00817183020448.
Distribution
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