Reported Sep 9, 2015 · Terminated
Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- 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 HQC3FMC -- Product Usageto measure flow intra-operatively
- Lot codes and dates
- Serial Numbers
HQC3FMC2501HQC3FMC2502HQC3FMC2503HQC3FMC2504HQC3FMC2505HQC3FMC2506HQC3FMC2507HQC3FMC2508HQC3FMC2509HQC3FMC2510HQC3FMC2511HQC3FMC2512HQC3FMC2513HQC3FMC2514HQC3FMC2515HQC3FMC2516HQC3FMC2517HQC3FMC2518HQC3FMC2519HQC3FMC2520HQC3FMC2521HQC3FMC2522HQC3FMC2523HQC3FMC2524HQC3FMC2525HQC3FMC2526HQC3FMC2527HQC3FMC2528HQC3FMC2529HQC3FMC2530HQC3FMC2531HQC3FMC2532HQC3FMC2533HQC3FMC2534HQC3FMC2535HQC3FMC2636
- Serial Numbers
- Amount recalled
- Domestic: 36 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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