Z-1253-2025 Class I Ongoing
FDA device recall Z-1253-2025 was initiated by Baxter Healthcare Corporation on February 5, 2025 and is designated Class I. Reason for recall: There is the potential for missing motor mounting screws, which may have occurred during the servicing process. The recall status is ongoing. Affected quantity: 66 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2025
- Initiation Date
- February 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 units
Product Description
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Reason for Recall
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Distribution Pattern
US: Nationwide
Code Information
UDI/DI 00085412091570, Serial Numbers: 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302, 775486, 778837, 785425, 793453, 795240, 798065, 814485, 818850, 826637, 850214, 850854, 851500, 854157, 855803, 863354, 870307, 873114, 876483, 877014, 877102, 889153, 896292, 900181, 906422, 907176, 912242, 913562, 927864, 938265, 958176, 962828, 963975, 965158, 974676, 981605, 982459, 984154, 986132, 986634, 989053, 993087, 994417, 994842, 995538, 997153, 1006359, 1011058, 1013925, 1014064, 1014529, 1014856, 1017150, 1017546, 1018229, 1018703, 1024109