Mirandola, N/A, Italy
QURA S.R.L. recalls
1 recall recorded since 2018, most recently on 22 March 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 March 2021
- Terminated
- 22 April 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of South Carolina.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2277-2021
- Spectrum Medical Quantum Standard heat exchanger
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.