Z-0085-2025 Class II Ongoing
FDA device recall Z-0085-2025 was initiated by LEICA BIOSYSTEMS NUSSLOCH GMBH on September 4, 2024 and is designated Class II. 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 the… The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2024
- Initiation Date
- September 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
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 Pattern
US Nationwide distribution.
Code Information
UDI/DI 04049188066237, Serial Number 990