Abl800 Flex recall
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Why was Abl800 Flex recalled?
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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: 902-754R2692N002 and 902-754R2692N001
- Product
- ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
- Recalling firm
- Radiometer Medical ApS
- Quantity
- 2 units
- Distribution
- US: in the state of California
- Recall date
- May 6, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)