Quanta System, S.p.A. Recall 87814
Description: Quanta System Sterile Optical Laser Fiber, reusable
Quanta System, S.p.A. Recall 87814 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1844-2021 |
| Event ID | 87814 |
| Event Description | Quanta System Sterile Optical Laser Fiber, reusable |
| Product Type | Devices |
| Distribution | Nationwide distribution via 6 US distributors |
| Quantity | 307 |
| Recall Reason | Product sterility is potentially compromised. |
| Device Classification | 20210616 |
| Device Code Info | 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 |
| Center Classification Date | 20210609 |
| Recall Initiation Date | 20210427 |
| Recalling Firm | Quanta System, S.p.A. |
| Initial Notification | Letter |
| Similar To |