LEICA BIOSYSTEMS NUSSLOCH GMBH Recall 95323
Description: Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
LEICA BIOSYSTEMS NUSSLOCH GMBH Recall 95323 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0088-2025 |
| Event ID | 95323 |
| Event Description | Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 25 units |
| Recall Reason | 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. |
| Device Classification | 20241023 |
| Device Code Info | 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, 1679092001, 2542042004, 1771, 1885032002, 2682092004, 2376112003, 2774122004, 1114, 1749112001, 1997072002; d) Material Number 1491900UVU2, UDI/DI 04049188002570, Serial Numbers: 3243052006 |
| Center Classification Date | 20241015 |
| Recall Initiation Date | 20240904 |
| Recalling Firm | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Initial Notification | Letter |
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