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
    • HQD3FMC3763
    • HQD3FMC3764
    • HQD3FMC3765
    • HQD3FMC3766
    • HQD3FMC3767
    • HQD3FMC3768
    • HQD3FMC3769
    • HQD3FMC3770
    • HQD3FMC3771
    • HQD3FMC3772
    • HQD3FMC3773
    • HQD3FMC3774
    • HQD3FMC3775
    • HQD3FMC3776
    • HQD3FMC3777
    • HQD3FMC3778
    • HQD3FMC3779
    • HQD3FMC3780
    • HQD3FMC3781
    • HQD3FMC3782
    • HQD3FMC3783
    • HQD3FMC3784
    • HQD3FMC3785
    • HQD3FMC3786
    • HQD3FMC3787
    • HQD3FMC3788
    • HQD3FMC3789
    • HQD3FMC3790
    • HQD3FMC3791
    • HQD3FMC3792
    • HQD3FMC3793
    • HQD3FMC3794
    • HQD3FMC3795
    • HQD3FMC3796
    • HQD3FMC3797
    • HQD3FMC3798
    • HQD3FMC3799
    • HQD3FMC3800
    • HQD3FMC3801
    • HQD3FMC3802
    • HQD3FMC3803
    • HQD3FMC3804
    • HQD3FMC3805
    • HQD3FMC3806
    • HQD3FMC3807
    • HQD3FMC3814
    • HQD3FMC3815
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Transonic Systems Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 18, 2016 · Data as of Sep 19, 6:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.