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
Summary
The FDA issued a Class I for Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software V by Zyno Medical LLC. Reason: There is a defect in the air-in-line software algorithm..
Details
Source
Device Recall
External ID
Z-0005-2025
Action Date
2024-10-16
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: Z-800 - 00814371020006 Z-800W - 00814371020020 Z-800F - 00814371020013 Z-800WF - 00814371020037 Lot Numbers: 190722360 20110921-SH 20111005-SH 20111102-SH 20111212-SH 20120105-SH 20120222-SH 20120501-SH 20120612-SH 20120719-SH 20120809-SH 20190809-SH 20120910-SH-1 20121213-sh 20130123-SH 20130227-SH 20120417-SH 20130511-SH 20130517-SH 20130609-SH 20130701-SH 20130812-SH 20131024-SH
Quantity Affected: 34,994 units (1819 units still need correction)
Reason for Recall
There is a defect in the air-in-line software algorithm.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-13
Company
Natick, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zyno Medical LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zyno Medical LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zyno Medical LLC have FDA actions?
Zyno Medical LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0005-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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