Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Reported: October 16, 2024 Initiated: September 13, 2024 #Z-0005-2025
Product Description
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Reason for Recall
There is a defect in the air-in-line software algorithm.
Details
- Recalling Firm
- Zyno Medical LLC
- Units Affected
- 34,994 units (1819 units still need correction)
- Distribution
- US Nationwide.
- Location
- Natick, MA
Frequently Asked Questions
What product was recalled? ▼
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z. Recalled by Zyno Medical LLC. Units affected: 34,994 units (1819 units still need correction).
Why was this product recalled? ▼
There is a defect in the air-in-line software algorithm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Critical. Recall number: Z-0005-2025.
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