LEICA BIOSYSTEMS NUSSLOCH GMBH: Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samp

Hazard

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.

Details from the source

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: US Nationwide distribution. Quantity: 30 units Lot/code info: 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,

UPC codes

14047742467, 04049188053992, 04049188002501, 04049188002488, 04049188002464

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.