Reported Sep 9, 2015 · Terminated
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
Transonic Systems 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: Transonic Systems Inc · 34 Dutch Mill Rd · Ithaca, NY · 14850-9785
Is this the product you have?
- Transonic Flow Probe, 3 mm
- Catalog Number HQD3FMC -- Product Usageto measure flow intra-operatively
- Lot codes and dates
- Serial Numbers
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
- Serial Numbers
- Amount recalled
- Domestic: 35 units, Foreign: 12 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
This product could cause temporary or reversible health problems — stop using it.
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