Reported Sep 9, 2015 · Terminated
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- 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, 4 mm
- Catalog Number HQD4FMC -- Product Usageto measure flow intra-operatively
- Lot codes and dates
- Serial Numbers
HQD4FMC3504HQD4FMC3505HQD4FMC3506HQD4FMC3507HQD4FMC3508HQD4FMC3509HQD4FMC3510HQD4FMC3511HQD4FMC3512HQD4FMC3513HQD4FMC3514HQD4FMC3515HQD4FMC3516HQD4FMC3517HQD4FMC3518HQD4FMC3519HQD4FMC3520
- Serial Numbers
- Amount recalled
- Domestic: 15 units, Foreign: 2 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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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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