FDA recall Z-1844-2021
Quanta System, S.p.A. · Class II · device
Product
Quanta System Sterile Optical Laser Fiber, reusable
Reason for recall
Product sterility is potentially compromised.
Distribution
Nationwide distribution via 6 US distributors
Key facts
- Status
- Terminated
- Initiation date
- 2021-04-27
- Report date
- 2021-06-16
- Termination date
- 2023-09-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Samarate, N/A, Italy
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1844-2021