Recall Z-1842-2021
Quanta System, S.p.A. · initiated April 27, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Olympus Sterile Optical Laser Fiber, single use and reusable
Codes / lots: 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…
Reason for recall
Product sterility is potentially compromised.
FDA-determined cause: Process control
Action taken
The recalling firm is sending recall notification letters to its consignees for further dissemination to the user level. Consignees are asked to cease use of impacted product, quarantine impacted goods and dispose of goods in accordance with local regulations. Consignees should complete and return the acknowledgement form.
Details
- Recall number
- Z-1842-2021
- Initiated
- April 27, 2021
- Terminated
- September 5, 2023
- Product code
- GEX – Powered Laser Surgical Instrument
- Quantity
- 26925 units
- Distribution
- Nationwide distribution via 6 US distributors
- Recalling firm
- Quanta System, S.p.A., Samarate
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1843-2021 Class II | Quanta System Sterile Optical Laser Fiber, single useProduct sterility is potentially compromised. | 04/27/2021Terminated |
| Z-1844-2021 Class II | Quanta System Sterile Optical Laser Fiber, reusableProduct sterility is potentially compromised. | 04/27/2021Terminated |