Cryostat Model CM1950 Lacks Warning on Flammable Spray Use
Leica Biosystems is recalling the Cryostat Model CM1950 due to missing warnings about using flammable freezing sprays in the device. Flammable sprays can ignite inside the chamber, potentially causing serious injuries.
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 for a medical device with potential fire and serious injury hazard from flammable sprays. No reported illnesses or injuries stated in source. Fits rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Leica Biosystems Nussloch GmbH is recalling 30 units of the Cryostat Model CM1950 distributed nationwide in the United States. The device is used in laboratory and medical settings for freezing and sectioning tissue samples.
The recall addresses a labeling deficiency: the cryostat's labeling did not include specific warnings about the use of flammable freezing sprays inside the device chamber. Post-market surveillance revealed that some customers were using flammable freezing sprays for this purpose. Because these sprays are flammable, they can potentially ignite inside the chamber, creating a fire hazard that could cause serious injuries to laboratory personnel.
The affected units are identified by their material numbers and serial numbers as documented by the manufacturer. Customers with these units should contact Leica Biosystems for updated labeling and guidance.
The recalled product
- Product
- Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Hazard
- fire
- burn-injury
- mis-labeling
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 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
Distribution
Distributed nationwide across the United States.
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