LEICA BIOSYSTEMS NUSSLOCH GMBH: Medical Device Recall in 2024 - (Recall #: Z-0090-2025)

Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples

Class II

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

a) Material Number 14047033518, UDI/DI 04049188065599, Serial Numbers: 5013012008, 3151052002, 3559082003; b) Material Number 14903050S01, UDI/DI 04049188003270, Serial Numbers: 3641, 4119012005, 5212102008, 4002102004, 3944092004, 3137042002, 3683122003, 5119, 4125022005, 4171032005, 3954092004, 2636102000, 3847052004, 4387122005, 4585092006, 4734022007, 3951092004, 3342112002, 5208082008, 4575092006, 4521052006, 2529052000, 2605, 4384102005, 4538062006, 4807, 4269062005, 2700122000, 3157052002, 4094012005, 4503042006, 3564082003, 4654, 2857072001, 3874062004, 2418022000, 3417012003, 4572082006, 3349, 3748022004, 4850072007, 4948102007, 3588092003, 3136042002, 4415122005, 4454022006, 3240072002, 5104052008, 3009012002, 4142, 4014112004, 2421022000, 3376, 3901072004, 3163052002, 3917072004, 2781042001, 4223052005, 4301092005, 5131062008, 4724022007, 2676112000, 3589092003, 4145, 4569082006, 3508, 2533062000, 4311092005, 4317092005, 4335092005, 4795052007, 5207, 4573082006, 5152072008, 5159082008, 3277092002, 3662112003, 3078032002, 3956092004, 4708022007, 4127022005, 3677122003, 4845, 3260092002, 3394, 3037012002, 4698012007, 5011012008, 2891082001, 3540072003, 3869062004, 2525052000, 4514052006, 4299072005, 3915042004, 5083, 3307102002, 5155082008, 3227072002, 3952092004, 5007012008, 5088, 2392121999, 3162052002, 3346112002, 4394, 3738022004, 3758032004, 5015012008, 4735022007, 2840062001, 3219072002, 3755022004, 4310092005, 4445012006, 5004122007, 4819062007, 3759032004, 4851, 3093032002, 3945, 3434022003, 4270062005, 4755, 4169032005, 4004102004, 2583072000, 2791/4.2001, 3396, 3824, 4655112006, 3044022002, 3832, 4853082007, 5197102008, 4193032005, 4242, 4764032007, 4781, 5018012008, 2580072000, 4952102007, 2774032001, 4797, 5171082008, 5082042008, 3548072003, 3526062003, 4774, 4320092005, 4124022005, 2943102001, 3375122002, 4801052007, 5224112008; c) Material Number 14903050S02, UDI/DI (01)04049188003201, Serial Numbers: 2624052001, 4802052007, 2633092000, 3187062002, 3908072004, 3459032003, 2890082001, 3783, 3609092003, 2627092000, 3344112002, 3795042004, 2853072001, 3401102003, 4393, 4391102005; d) Material Number 14903050S03, UDI/DI 04049188003188, Serial Numbers: 4926092007, 4644112006, 3004012002, 5226, 4958, 4518, 3644, 5070

US Nationwide distribution.

Voluntary: Firm initiated