Leica Biosystems Cryostat Model CM3050 S lacks warning label for flammable sprays
Leica cryostat units lack a warning about flammable freezing sprays that can ignite in the chamber. The company discovered through post-market surveillance that users were applying these flammable sprays without being warned of the fire 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: This is an FDA Class II recall of a risk-of-harm product with no reported injuries or hospitalizations. The hazard involves potential ignition of flammable sprays within the device, but since no injury has been reported and the risk is theoretical, the severity is 3 per the rubric.
Plain-English summary
Leica Biosystems is recalling Cryostat Model Number CM3050 S units due to missing safety labeling. The cryostat is used for freezing and sectioning tissue samples in laboratory and medical settings. Post-market surveillance identified that customers were using flammable freezing sprays inside the cryostat chamber without being warned of the flammability hazard.
Flammable freezing sprays can ignite within the cryostat, potentially causing serious injuries. While the flammability of these sprays is marked on the spray containers themselves, the cryostat labeling did not include a specific warning about this risk prior to 2019.
A total of 187 units have been distributed nationwide in the United States. The affected product includes multiple material numbers and serial numbers as specified by the FDA.
Customers using affected units should consult updated safety information and instructions from Leica Biosystems before continuing to use flammable sprays with the cryostat.
The recalled product
- Product
- Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Hazard
- fire-hazard
- 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 14047033518
- UDI/DI 04049188065599
- Serial Numbers: 5013012008
- 3151052002
- 3559082003
- b) Material Number 14903050S01
- UDI/DI 04049188003270
- Serial Numbers: 3641
- 4119012005
- 5212102008
- 4002102004
- 3944092004
- 3137042002
- 3683122003
- 5119
- 4125022005
- 4171032005
- 3954092004
- 2636102000
- 3847052004
Distribution
Distributed nationwide across the United States.
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