Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples

Reason: 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.

Code information: a) Material Number 14045227382, UDI/DI 04049188075840, Serial Numbers: 1198121999, 383051996; b) Material Number 14901900100, UDI/DI 04049188003324, Serial Numbers: 703111997, 1018021999, 1538042001, 2058, 629071997, 2994, 1170111999, 3686102007, 3698; c) Material Number 14901900700, UDI/DI 04049188003300, Serial Numbers: 1267032000, 2602062004, 1577052001, 1679092001, 2542042004, 1771, 1885032002, 2682092004, 2376112003, 2774122004, 1114, 1749112001, 1997072002; d) Material Number 1491900UVU2, UDI/DI 04049188002570, Serial Numbers: 3243052006

Distribution pattern: US Nationwide distribution.