Z-1842-2021 Class II Terminated
FDA device recall Z-1842-2021 was initiated by Quanta System, S.p.A. on April 27, 2021 and is designated Class II. Reason for recall: Product sterility is potentially compromised. The recall status is terminated (terminated September 5, 2023). Affected quantity: 26925 units.
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
- 26925 units
Product Description
Olympus Sterile Optical Laser Fiber, single use and reusable
Reason for Recall
Product sterility is potentially compromised.
Distribution Pattern
Nationwide distribution via 6 US distributors
Code Information
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