Home / Recalls / Quanta System, S.p.A. / Z-1844-2021

Z-1844-2021 Class II Terminated

Recalled by Quanta System, S.p.A. — Samarate, N/A

Recall Details

Product Type
Devices
Report Date
June 16, 2021
Initiation Date
April 27, 2021
Termination Date
September 5, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
307

Product Description

Quanta System Sterile Optical Laser Fiber, reusable

Reason for Recall

Product sterility is potentially compromised.

Distribution Pattern

Nationwide distribution via 6 US distributors

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

Other recalls by Quanta System, S.p.A.

  • Z-1843-2021 Class II — Quanta System Sterile Optical Laser Fiber, single use (April 27, 2021)
  • Z-1842-2021 Class II — Olympus Sterile Optical Laser Fiber, single use and reusable (April 27, 2021)
  • Z-0692-2013 Class II — Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair r (November 7, 2012)
  • Z-0691-2013 Class II — Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatme (November 7, 2012)
  • Z-0693-2013 Class II — Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. (November 7, 2012)