FDAFDA · Food and drugs·Recall number Z-1295-2015
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.
Published March 25, 2015 · Recall initiated: February 17, 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
Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Transonic Systems Inc
- Distributor
- Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
- Lot
- Serial Numbers HD03A60004; HD03A81167; HD03A81225; HD03A81237; HD03A91338; HD03A91394; HD03A91406; HD03B01461; HD03B21782; HD03B21803; HD03A60020; HD03A71082; HD03A81207; HD03A91255; HD03A91316; HD03Bl1679; HD03B11684; HD03B11705; HD03B21812; HD03B31971; HD03A81240; HD03A71086; HD03B01459; HD03B01594; HD03B11667; HD03B42175; HD03B42160; HD03B42161; HD03A91258; HD03A70046; HD03B31901
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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