FDAFDA · Food and drugs·Recall number Z-2726-2015
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
Published September 9, 2015 · Recall initiated: July 27, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Transonic Systems Inc
- Distributor
- Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
- Lot
- Serial Numbers: HQD2FMC2797, HQD2FMC2873, HQD2FMC2874, HQD2FMC2875, HQD2FMC2876, HQD2FMC2877, HQD2FMC2878, HQD2FMC2879, HQD2FMC2880, HQD2FMC2881, HQD2FMC2882, HQD2FMC2883, HQD2FMC2884, HQD2FMC2885, HQD2FMC2886, HQD2FMC2888, HQD2FMC2889, HQD2FMC2890, HQD2FMC2908
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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