Quanta System, S.p.A. recalls Olympus Sterile Optical Laser Fiber, single use and reusable

Hazard / Issue

Product sterility is potentially compromised.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/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