Leica Cryostat Model CM1100 Recalled for Fire Risk from Flammable Freezing Sprays
Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (fire hazard from flammable freezing sprays) with no reported injuries to date. The labeling deficiency creates potential for serious burn injuries, aligning with High severity criteria for products where injury has not yet been reported.
Plain-English summary
The Leica Biosystems Cryostat Model CM1100 (Material Number 14046931130, UDI 04049188066237) is being recalled for inadequate labeling regarding the hazards of using flammable freezing sprays with the device.
Post-market surveillance identified that some customers are using flammable freezing sprays within the cryostat chamber. Flammable freezing sprays can potentially ignite, creating a fire hazard that could cause serious injuries. The cryostat's labeling did not include specific warnings about this hazard prior to 2019.
The device was distributed nationwide in the United States. Users should avoid using flammable freezing sprays with this cryostat and should consult the manufacturer regarding safe operation.
The recalled product
- Product
- Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Hazard
- fire
- burn-injury
- missing-warnings
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 04049188066237
- Serial Number 990
Distribution
Distributed nationwide across the United States.
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