Reported Sep 9, 2015 · Terminated
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- 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, 2 mm
- Catalog Number HQD2FMC -- Product Usageto measure flow intra-operatively
- Lot codes and dates
- Serial Numbers
HQD2FMC2797HQD2FMC2873HQD2FMC2874HQD2FMC2875HQD2FMC2876HQD2FMC2877HQD2FMC2878HQD2FMC2879HQD2FMC2880HQD2FMC2881HQD2FMC2882HQD2FMC2883HQD2FMC2884HQD2FMC2885HQD2FMC2886HQD2FMC2888HQD2FMC2889HQD2FMC2890HQD2FMC2908
- Serial Numbers
- Amount recalled
- Domestic: 8 units, foreign: 11 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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