Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
Enforcement
- Recall Number
- Z-0087-2025
- Event ID
- 95323
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 23, 2024
- Initiation Date
- September 4, 2024
- Classification Date
- October 15, 2024
- Address
- Heidelberger Str. 17-19, Nussloch, N/A, Germany
Description
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
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.
a) Material Number 14047131148, UDI/DI 04049188064790, Serial Numbers: 598061998, 1874062001, 329111997, 370121997, 175081997, 517041998, 376021998, 702071998, 2935062002, 333041998, 693071998, 3524062003; b) Material Number 14901850001, UDI/DI 04049188003423, Serial Numbers: 1922112000, 2396082001, 2032122000, 1850092000, 3728, 1885, 3156102002, 3441032003, 1684082001, 3682102003, 3080102002, 4791, 1439, 3517062003, 1186071999, 5742, 3976022004, 217091997, 960021999, 2097022001, 4660052005, 3107, 2805, 3425032003, 1884092000, 729101998, 1407121999, 1678062000, 2870052002, 3346022003, 1716062000, 3222112002, 2144042001, 4211072004, 1542032000, 3069102002, 469021998, 4955032006, 5674052008, 2873052002, 915121998, 2812042002, 1742072000, 4720, 5508, 4947032006, 4137052004, 3318012003, 3357032003, 4548032005, 1110061999, 4722062005, 4721, 5507, 2925, 4129042004, 2628122001, 2509102001, 2136042001, 4118, 3508062003, 3421, 3400022003, 4180062004, 3496052003, 3321012003, 5307032007, 5620032008, 1336, 3322012003, 3980, 3276122002, 3306012003, 979021999, 2068022001, 1887092000, 3207, 1031031999, 2968072002, 2788032002, 4231072004, 794101998, 454051999, 5668, 4527022005, 952021999, 1663, 1387121999, 2172, 3760112003, 2936062002, 1076051999, 3558062003, 2939062002, 2906052002, 4264092004, 4471, 3333022003, 2363092001, 3876022004, 2586122001, 3435042003, 4252092004, 2903052002, 5064, 5755, 1856092000, 777101998, 5361, 5607, 2736022002, 2750022002, 917011999, 3689102003, 3197, 2260062001, 4049042004, 4925022006, 1843092000, 5315042007, 4167, 2911082002, 447031998, 2461102001, 3415, 3603082003, 904, 2145022001, 2028122000, 5660052008, 5052, 2861042002, 1321101999, 453, 3008, 3096102002, 2717022002, 3193112002, 3030082002, 961021999, 3202, 1153061999, 475031998, 2782, 5465, 5579, 3631092003, 5030062006, 3168102002, 3251122002, 5141092006, 3927, 2227052001, 757101998, 573051998, 5267, 2707, 3598, 220042001, 4833102005, 3024082002, 2890052002, 4593032005, 2335072001, 5108092006, 3488, 1878062001, 2757032002, 1063041999, 3679, 1310101999, 1561032000, 3647092003, 4466012005, 2798032002, 4159, 5095082006, 4589032005, 3068102002, 2632012002, 1315, 2215042001, 3869022004, 2425092001, 4160052004, 3354022003, 4774, 5001052006, 5740092008, 3445, 4898, 4954032006, 1164071999, 5355062007, 4976042006, 4728062005, 3407032003, 5727, 4588, 5280, 5659, 5814, 4639052005, 416011998, 3316, 3499052003, 1121061999, 5805112008, 2909062002, 5716072008, 4202, 4816, 4355102004, 2780032002, 4228, 2089022001, 1776082001, 2139, 5335, 4861112005, 608051998, 1753, 2735022002, 2599112001, 5393072007, 5813122008, 5531122007, 332111997, 3025, 4608032005; c) Material Number 14901850001R0501, UDI/DI 04049188003423, Serial Numbers: 4723; d) Material Number 1491850UVUL, UDI/DI 04049188002730, Serial Numbers: 216052005, 482, 765012007, 332, 1067, 1187012008, 1208, 417, 511072006, 1095102007, 1347, 1200, 970082007, 370, 895, 494062006, 454082006, 870052007, 1488, 672122006, 1149122007, 1059, 1345, 658122006, 1196012008, 301092005, 772012007, 708012007, 709012007, 655112006, 802022007, 868052007, 885, 698122006, 513072006, 378, 1453, 991082007, 201052005, 1076102007, 1389, 997, 610, 265082005, 671122006, 896, 1137, 429032006, 1317052008, 949, 987082007, 189, 646112006, 597, 1307042008, 1128112007, 792022007, 771, 576092006, 1272, 1259032008, 1524, 382, 1313052008, 1255032008, 1325, 1017, 1016, 1055102007, 702, 345112005, 1044102007, 1047102007, 1403, 526, 602102006, 455042006, 894, 1320052008
US Nationwide distribution.
322 units