BEUDAMED
    FDA Enforcement Class II Terminated

    Olympus Sterile Optical Laser Fiber, single use and reusable

    Recall: Z-1842-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1842-2021
    Event ID
    87814
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quanta System, S.p.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 16, 2021
    Initiation Date
    April 27, 2021
    Classification Date
    June 9, 2021
    Termination Date
    September 5, 2023
    Address
    Via Acquedotto 109, N/A, Samarate, N/A, N/A, Italy

    Description

    Olympus Sterile Optical Laser Fiber, single use and reusable

    Reason

    Product sterility is potentially compromised.

    Code Info

    Product Part Numbers: OFH302721 - lots H182604, H182605, H184521, H204109, H204110, H204111, H204112 OFH002711 - lots H182606, H182607, H182608, H182609, H182701, H182702, H182703, H182704, H182709, H204113, H204114, H204115, H204116, H204117, H204134 OFH302711 - lots H181600, H182011, H184001, H184002, H190309, H190310, H190311, H190312, H194031, H194032, H194033, H194034, H194035, H194111, H194112, H194113, H194114, H194115, H194116, H194117, H194118, H194119, H194120, H194121, H194122, H194123, H194124, H194319, H194320, H194321, H194322, H194323, H194324, H200831, H200832, H200833, H200834, H200835, H200836, H200837, H204120, H204121, H204122, H204201, H204826 OFH009911 - lots H181600, H184015, H184522, H184523, H191501, H191502, H191503, H191504, H191505, H191506, H191507, H191508, H191509, H202018, H202019, H202020, H202816, H202817, H202819, H202820, H204202, H204203, H204204 OFH005511 - lots H182012, H184012, H184013, H184014, H195016, H195017, H195018, H195019, H195020, H202813, H202814, H204509 OFH703611 - lots H181600, H182003, H182004, H182009, H183919, H183920, H183921, H183922, H183923, H183924, H184009, H184010, H184011, H184514, H184515, H184625, H184626, H184627, H184628, H194314, H194315, H194316, H194317, H194318, H194609, H194610, H194611, H194612, H194613, H194614, H194615, H202030, H202031, H202032, H202033, H202034, H202035, H202036, H202037, H202038, H202039, H202808, H202809, H202811, H202812, H204131, H204132, H204133 OFH702711 - lots H181600, H181601, H181602, H182001, H182002, H184006, H184007, H184008, H184629, H184630, H194102, H194103, H194104, H194105, H194106, H194201, H194202, H194203, H194204, H194205, H194325, H194616, H194617, H194618, H200411, H200412, H200916, H200917, H200918, H200919, H200920, H200921, H200922, H200923, H200924, H203803, H203804, H203805, H203806, H203807, H203809, H203810, H203811, H203812, H203813, H203814, H204123, H204124, H204125, H204126, H204127, H204128, H204129, H204130, H204901, H204902, H204903, H204904, H204905 OFH002011 - lots H181600, H182010, H184003, H184004, H184005, H184517, H184518, H184519, H184520, H190304, H190305, H190306, H190307, H190308, H194107, H194108, H194711, H194712, H194713, H194714, H194715, H194716, H194717, H194718, H194719, H194720, H200401, H200402, H200403, H200404, H200405, H200406, H200407, H200408, H200409, H200410, H200901, H200902, H200903, H200904, H200905, H200906, H200907, H200908, H200909 OFH002013 Lots H183616 and H183618 OFH002713 Lots H193012, H193014, H193015, H193016, H193017, H193018, H194101, H202823, H202824 OFH005513 Lot H181600 OFH702713 Lot H181600 OFH703613 Lots H183619, H183620, H183621, H183622, H204118, H204119

    Distribution

    Nationwide distribution via 6 US distributors

    Quantity

    26925 units