Z-0523-2025 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- September 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product Description
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional.
Reason for Recall
For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
Distribution Pattern
Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.
Code Information
Model/Catalog Number: Z-800WF; UDI-DI: 00814371020006; Serial Numbers: 500346, 500347, 500348, 500349, 500350, 500351, 500352, 500353, 500354, 500355, 500356, 500357, 500358, 500359, 500360, 500361, 500362, 500363, 500364, 500365, 500367, 500368, 500369, 500370, 500371, 500373, 500374, 500375, 500376, 500377, 500378, 500384, 500385, 500386, 500388, 500389, 500390, 500391, 500392, 500393, 500394, 502634, 503435, 503716, 503799, 503917, 503921, 504534, 504807, 504808, 504809, 504810, 504811, 504812, 504813, 504814, 504815, 504816, 504817, 504818, 504819, 504820, 504821, 504822, 504823, 504824, 504825, 504826, 504827, 504828, 504829, 504830, 504831, 504832, 504834, 504835, 504836, 504838, 505369, 505425, 505430, 505432, 505437, 505626, 505627, 505628, 505629, 505630, 505631, 505632, 505633, 505635, 505637, 505638, 505691, 505692, 505693, 506585, 506982, 506983,