Leica Cryostat Model CM1900 Lacks Warning on Flammable Sprays
Leica Biosystems is recalling the Cryostat Model CM1900 because its labeling lacks a warning about using flammable freezing sprays in the chamber. The sprays can ignite, creating a serious fire and burn hazard.
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: FDA Class II recall involving a risk-of-harm product where injury has not yet been reported. The hazard—fire and burn injury from ignition of flammable freezing sprays—is serious, but the source text states no illnesses or injuries have been reported, keeping the score at the maximum of 3 per the severity rubric.
Plain-English summary
Leica Biosystems Nussloch GmbH is recalling the Cryostat Model CM1900 due to a labeling deficiency. The device was used in laboratory settings to freeze and section tissue samples. Prior to 2019, the device labeling did not include a specific warning about the use of flammable freezing sprays within the cryostat chamber.
The recall was initiated following post-market surveillance that identified customers using flammable freezing sprays in the cryostat chamber. Flammable freezing sprays can potentially ignite inside the chamber, creating a serious risk of burn injuries and fires. Although the sprays themselves carry flammability labels, the cryostat device lacked a specific warning against their use.
A total of 25 units with specific serial numbers were distributed nationwide in the United States. The recall addresses the labeling deficiency to ensure users understand the fire and burn hazards associated with using flammable freezing sprays in the device.
The recalled product
- Product
- Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Hazard
- fire
- burn-injury
- missing-warning
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 (20)
- 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
Distribution
Distributed nationwide across the United States.
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