Northgate Technologies Recalls 9 FR AUTOLITH Probes for Biocompatibility Testing Failure
Northgate Technologies is recalling 9 FR AUTOLITH probes because a lot failed biocompatibility testing. The recall covers 298 boxes distributed nationwide.
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: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source cites a biocompatibility test discrepancy without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Northgate Technologies, Inc. is recalling 9 FR AUTOLITH probes (NTI Catalog Number 9-900-54). These medical devices are used for the fragmentation of urinary, renal, and biliary calculi. The recall involves 298 boxes, with 3 units per box, which were distributed nationwide in the United States.
The recall was initiated as part of an investigation into a biocompatibility test discrepancy where a specific lot failed biocompatibility testing. The source text does not specify the exact nature of the biocompatibility failure or the specific lot numbers affected beyond the general catalog number.
Healthcare facilities and consumers should stop using these probes and contact Northgate Technologies, Inc. for further instructions on return or replacement. The source text does not provide specific contact details or a deadline for the recall.
The recalled product
- Product
- Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- Manufacturer
- Northgate Technologies, Inc.
- Hazard
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)
- NTI Catalog Number 9-900-54.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Northgate Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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