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.
Reported: December 4, 2024 Initiated: September 30, 2024 #Z-0523-2025
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.
Details
- Recalling Firm
- Zyno Medical LLC
- Units Affected
- 100 units
- Distribution
- Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.
- Location
- Natick, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zyno Medical LLC. Units affected: 100 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2024. Severity: Low. Recall number: Z-0523-2025.
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