Product Safety Recalls

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Quanta System, S.p.A. Recall 87814

Description: Quanta System Sterile Optical Laser Fiber, reusable

Quanta System, S.p.A. Recall 87814 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1844-2021
Event ID87814
Event DescriptionQuanta System Sterile Optical Laser Fiber, reusable
Product TypeDevices
DistributionNationwide distribution via 6 US distributors
Recall ReasonProduct sterility is potentially compromised.
Device Classification20210616
Device Code InfoProduct 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 Date20210609
Recall Initiation Date20210427
Recalling FirmQuanta System, S.p.A.
Initial Notification Letter
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