Northgate Technologies Recalls ACMI 9FR Probes Due to Biocompatibility Failure
Northgate Technologies is recalling ACMI 9FR probes used for stone fragmentation because a lot failed biocompatibility testing.
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 involves a medical device where a lot failed biocompatibility testing, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Northgate Technologies, Inc. is recalling ACMI 9FR Probes (E4-9F), manufactured for Olympus Surgical Technologies, America (OSTA). The product is identified by NTI Catalog Number 72-00198-0. These probes are used for the fragmentation of urinary, renal, and biliary calculi.
The recall was initiated following an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. The source text does not specify the exact nature of the biocompatibility failure or any specific adverse health events.
The recall involves 1,238 boxes, with 3 units per box. The products were distributed nationwide in the United States. The source text does not provide specific instructions for consumers or healthcare providers regarding the return or disposal of the recalled devices.
The recalled product
- Product
- ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - 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 72-00198-0.
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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