Brand Name: Z-800 Infusion System Product Name: Z-800WF recall: Software Issue
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…
Why was Brand Name: Z-800 Infusion System Product Name: Z-800WF 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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,
- 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…
- Recalling firm
- Zyno Medical LLC
- Quantity
- 100 units
- Distribution
- Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.
- Recall date
- December 4, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)