Northgate Technologies, Inc. recalls Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/ren…
- Recall date
- March 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1883-2020
- FDA classification
- Class II
- Brand / firm
- Northgate Technologies, Inc.
- Sold / distributed
- US Nationwide distribution. No governmental.
Why it was recalled
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
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