Transonic Hemodialysis Monitor Recall Due to Inaccurate Flow Measurements
Transonic Systems Inc is recalling Hemodialysis Monitors that may display zero or low flow values, preventing accurate measurements during dialysis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device that may fail to provide critical measurements during dialysis, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Transonic Systems Inc is recalling the Transonic Hemodialysis Monitor, Model HD03, because the device may fail to obtain accurate measurements during dialysis procedures. The issue involves the device displaying zero or very low flow values, or failing to produce measurements in other modes such as recirculation, access flow, or cardiac output.
This recall affects 21 units distributed domestically in the United States and 10 units distributed in Australia, Canada, and South Korea. The devices are 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.
Users should stop using the affected devices and contact Transonic Systems Inc for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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 hemodi
- Manufacturer
- Transonic Systems Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers HD03A60004
- HD03A81167
- HD03A81225
- HD03A81237
- HD03A91338
- HD03A91394
- HD03A91406
- HD03B01461
- HD03B21782
- HD03B21803
- HD03A60020
- HD03A71082
- HD03A81207
- HD03A91255
- HD03A91316
- HD03Bl1679
- HD03B11684
- HD03B11705
- HD03B21812
- HD03B31971
Distribution
Distributed nationwide across the United States.
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