FDA Medical devices recall ·
Z-800 Infusion System Product Name: Z-800WF Model recall
- Recall number
- Z-0523-2025
- Date
- (initiated September 30, 2024)
- Company / brand
- Zyno Medical LLC
177 Pine St, Natick, MA, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 100 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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,
Distribution
Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.
States: Alabama Florida Louisiana Michigan Nebraska New Jersey Ohio Texas
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-0523-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.