Recall Z-1844-2021
Quanta System, S.p.A. · initiated April 27, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Quanta System Sterile Optical Laser Fiber, reusable
Codes / lots: Product Part Numbers: OAF002013 Lots A201003 OAF005513 Lots A184636, A192118, A193101 OAF006003 Lot A195008 OAF008003 Lots A193615, A194021 OAF008013 Lots A183623, A192119 OAF009903 Lots A193109, A193617 OAF009913 Lots A181350, A192910 OAF702713 Lots A182415, A193104, A194109, A194723 OAF703613 Lot A180150
Reason for recall
Product sterility is potentially compromised.
FDA-determined cause: Process control
Action taken
The recalling firm is sending recall notification letters to its consignees for further dissemination to the user level. Consignees are asked to cease use of impacted product, quarantine impacted goods and dispose of goods in accordance with local regulations. Consignees should complete and return the acknowledgement form.
Details
- Recall number
- Z-1844-2021
- Initiated
- April 27, 2021
- Terminated
- September 5, 2023
- Product code
- GEX – Powered Laser Surgical Instrument
- Quantity
- 307
- Distribution
- Nationwide distribution via 6 US distributors
- Recalling firm
- Quanta System, S.p.A., Samarate
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1842-2021 Class II | Olympus Sterile Optical Laser Fiber, single use and reusableProduct sterility is potentially compromised. | 04/27/2021Terminated |
| Z-1843-2021 Class II | Quanta System Sterile Optical Laser Fiber, single useProduct sterility is potentially compromised. | 04/27/2021Terminated |