LEICA BIOSYSTEMS NUSSLOCH GMBH: Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples

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: 1 unit Lot/code info: UDI/DI 04049188066237, Serial Number 990

UPC codes

04049188066237

Source

Official record: FDA (Device enforcement) ↗

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