Northgate Technologies, Inc. recalls ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 -…
- Recall date
- March 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1885-2020
- FDA classification
- Class II
- Brand / firm
- Northgate Technologies, Inc.
- Sold / distributed
- US Nationwide distribution. No governmental.
Why it was recalled
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
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.
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