This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
|
Pump Model |
Unique Device Identifier (UDI-DI) |
Software Revision |
|
Z-800 |
00814377102006 |
6.1.01 and 6.1.07z |
|
Z-800W |
00814371020020 |
3.1.32 and 3.1.64z |
|
Z-800F |
00814371020013 |
4.1.02 and 4.1.08z |
|
Z-800WF |
00814371020037 |
5.1.01 and 5.1.08z |
What to Do
- Do not use affected infusion pumps.
On September 13, 2024, Zyno Medical LLC sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:
- Stop using affected devices.
- Follow instructions to return these devices for software update.
- Complete the Zyno Medical Z-800, Z-800F, Z-800W, and Z-800WF Infusion Pump – Air-in-Line Software Issue – Response Verification Form which includes the following activities:
- Checking inventory for affected products.
- Verifying serial numbers.
- Confirming product location.
- Reporting any transferred product.
- Signing and dating the completed form.
- Make sure this notice reaches everyone who needs to be informed, including those at other locations if the devices have been transferred.
A representative from Zyno Medical’s partner company, Intuvie LLC, will contact customers to coordinate instructions for exchanging devices.
Reason for Recall
Zyno Medical is recalling certain Zyno Medical Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps due to a defect in the air-in-line software algorithm that may allow a 1.0 mL air bubble to be passed on to a patient.
The use of affected product may cause serious adverse health consequences, including air entering the blood vessels (vascular air embolism), fast and irregular heartbeat (tachyarrhythmia), heart attack (myocardial infarction), stroke, seizure, and death.
There have been two reported injuries. There have been no reports of death.
Device Use
Zyno Medical Z800 Infusion Systems are intended to provide infusion through the blood vessels (intravenous) of nutrition or essential (parenteral) fluids, blood, and blood products under the direction or supervision of a health care professional.
Contact Information
Customers in the U.S. with questions about this recall should contact their Zyno Medical local business partner or email feedback@intuvie.com.
Additional FDA Resources (listed in order of most to least recent):
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
