Reported Dec 4, 2024 · Ongoing
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is…
Zyno Medical LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zyno Medical LLC · 177 Pine St · Natick, MA · 01760-1331
Is this the product you have?
- Brand NameZ-800
- Infusion System Product NameZ-800WF
- Model/Catalog NumberZ-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
- Lot codes and dates
- Model/Catalog NumberZ-800WF
- UDI-DI00814371020006
- Serial Numbers
100 of 100 codes
500346500347500348500349500350500351500352500353500354500355500356500357500358500359500360500361500362500363500364500365500367500368500369500370500371500373500374500375500376500377500378500384500385500386500388500389500390500391500392500393500394502634503435503716503799503917503921504534504807504808504809504810504811504812504813504814504815504816504817504818
- Amount recalled
- 100 units
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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