Device product

Quanta System Sterile Optical Laser Fiber, reusable

Z-1844-2021

April 27, 2021

Class II

Product summary

Firm: Quanta System, S.p.A.
Event: Event 87814
Status: Terminated
Classification: Class II
Quantity: 307
Official record key: device-enforcement:Z-1844-2021

Official wording

Reason: Product sterility is potentially compromised.

Code information: 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

Distribution pattern: Nationwide distribution via 6 US distributors

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product sterility is potentially compromised.