Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Recall
- Recall Number
- Z-1183-2024
- Event Number
- 93857
- Firm
- Zyno Medical LLC
- FEI Number
- 3006575795
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- December 20, 2023
- Posted
- February 23, 2024
- Address
- 177 Pine St, Natick, MA, 01760-1331
Description
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
Zyno Medical LLC issued URGENT: Medical Device Correction Zyno Medical Z-800WF Infusion Pump -Alarm Volume Reversion Issue letter on 12/20/23 via Certified Mail. Letter states reason for recall, health risk and action to take: To address this issue, users can reset the alarm volume by accessing the Factory Settings (2) via the configuration menu on the pump and selecting the desired alarm volume. The chosen setting will remain on the pump until it is manually altered or until the initial workflow that triggered the reversion is repeated. Zyno Medical LLC is mitigating this alarm issue by conducting a voluntary medical device correction to downgrade the software from version 5.2.05 to version 5.1.87. Please note that the low volume alarm issue occurred with a specific software change that occurred in version 5.2.05 and the issue does not exist. Complete the attached Zyno Medical Z-800WF Infusion Pump - Alarm Volume Reversion Issue -Response Verification Form. This will include checking your inventory for affected products, verifying serial numbers, confirming product location, reporting any transferred product, and signing and dating the completed form. 3. A representative from Zyno Medical's distribution partner, lntuvie LLC, will be in contact with you to coordinate instructions on exchanging devices and the timing to remediate this action. 4. Pass this notice to the appropriate healthcare professional within your facility who needs to be informed and to any facility where the potentially affected devices have been transferred (if appropriate). Provide Zyno Medical with details of any affected devices that have been transferred to other facilities. If you have any questions or would like assistance, please contact your local Business Development Manager
Nationwide
574 units