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.
What this means for you
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
- mis-labeling
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
Distributed nationwide across the United States.
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