Reported May 13, 2020 · Terminated
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 -…
Northgate Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Northgate Technologies, Inc. · 1591 Scottsdale Ct · Elgin, IL · 60123-9361
Is this the product you have?
- ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog
- Number 72-00198-0 - Product UsageProbes are used for the fragmentation of urinary/renal and biliary calculi
- Lot codes and dates
- NTI Catalog Number 72-00198-0.
- Amount recalled
- 1238 boxes. 3 units per box.
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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