FDAFDA · Food and drugs·Recall number Z-1844-2021
Quanta System Sterile Optical Laser Fiber, reusable
Published June 16, 2021 · Recall initiated: April 27, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product sterility is potentially compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Quanta System, S.p.A.
- Distributor
- Nationwide distribution via 6 US distributors
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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