EDAN Telemetry Transmitter recall
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital…
Why was EDAN Telemetry Transmitter recalled?
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002
- Product
- EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital…
- Recalling firm
- Edan Diagnostics
- Quantity
- 7 units
- Distribution
- U.S. Nationwide distribution in the state of CA.
- Recall date
- February 26, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)