Z-0089-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2024
- Initiation Date
- September 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
a) Material Number 14047742467, UDI/DI 04049188053992, Serial Numbers: 492102008; b) Material Number 1491950C1US, UDI/DI 04049188002501, Serial Numbers: 432082008, 288032008, 581122008, 435082008, 380, 215012008, 427082008, 218012008, 287032008, 216012008, 291042008; c) Material Number 1491950C2US, UDI/DI 04049188002488, Serial Numbers: 524112008, 451082008, 420, 335, 476, 454, 398, 399072008; d) Material Number 1491950C3US, UDI/DI 04049188002464. Serial Numbers: 314042008, 508, 249032008, 318042008, 429, 328052008, 577122008, 407072008, 391072008, 356062008,