Northgate Technologies Recalls Autolith Uro-Tch 9FR Probes for Biocompatibility Failure
Northgate Technologies is recalling Autolith Uro-Tch 9FR probes because a lot failed biocompatibility testing. The recall covers 198 boxes distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Northgate Technologies, Inc. is recalling the Autolith Uro-Tch 9FR Probe 54CM (NTI Catalog Number 9-203-0543). These medical device probes are used for the fragmentation of urinary, renal, and biliary calculi. The recall involves 198 boxes, with 3 units per box, which were distributed nationwide in the United States.
The recall was initiated following an investigation into a biocompatibility test discrepancy where a specific lot of the probes failed biocompatibility testing. No specific injuries or illnesses have been reported in the source text.
Consumers and healthcare facilities should stop using the affected probes and contact Northgate Technologies for further instructions on return or replacement.
The recalled product
- Product
- AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - 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 9-203-0543.
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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