Spectrum Medical Quantum Standard heat exchanger recall
Spectrum Medical Quantum Standard heat exchanger
Why was Spectrum Medical Quantum Standard heat exchanger recalled?
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
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?
Batch Numbers: B000129, C000415, C000416, C000417
- Product
- Spectrum Medical Quantum Standard heat exchanger
- Recalling firm
- QURA S.R.L.
- Quantity
- 1088 units
- Distribution
- US Nationwide distribution in the state of South Carolina.
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)