Reported Mar 25, 2015 · Terminated
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained…
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 Hemodialysis Monitor
- Model HD03 -- Product UsageThe 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
- Lot codes and dates
31 of 31 products
Products covered by this recall # Product as published 1 Serial Numbers HD03A60004 2 HD03A81167 3 HD03A81225 4 HD03A81237 5 HD03A91338 6 HD03A91394 7 HD03A91406 8 HD03B01461 9 HD03B21782 10 HD03B21803 11 HD03A60020 12 HD03A71082 13 HD03A81207 14 HD03A91255 15 HD03A91316 16 HD03Bl1679 17 HD03B11684 18 HD03B11705 19 HD03B21812 20 HD03B31971 - Amount recalled
- Domestic: 21 units, Foreign: 10 units
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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