FDA Device Recall Z-0005-2025: Zyno Medical LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0005-2025.

Recall Res Number

Z-0005-2025

Recalling Firm / Manufacturer

Zyno Medical LLC

FEI Number

3006575795

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-09-13

Date Posted

2024-10-09

Date Terminated

N/A

Product Code

FRN

Event Number

95382

Product Quantity

34,994 units (1819 units still need correction)

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.

Action Details An "URGENT: MEDICAL DEVICE CORRECTION" notification letter dated 9/13/24 was sent to customers. Mitigation Zyno Medical LLC is mitigating this software issue by conducting a voluntary medical device correction to remove the faulty software and correctly install software that is free of this defect. Recommended Actions 1. Actions to Address the Issue During Use Note that only the devices listed in this letter are affected. No other products are involved in this action. Discontinue use of the affected device and proceed to the instructions for return of the device in Recommended Action below. 2. Actions to Correct the Issue Complete the attached Zyno Medical Z-800, Z-800F, Z-800W, and Z-800WF Infusion Pump Air-in-Line Software Issue Response Verification Form. This will include checking your inventory for the affected products, verifying serial numbers, confirming product location, reporting any transferred product, and signing and dating the completed form. A representative from Zyno Medical s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action. Pass this notice to the appropriate personnel who need to be informed if the identified devices have been transferred to another location. If you have any questions or would like assistance, please contact your local Business Development Manager. Contact Information: Customerservice@intuvie.com ***Update 1/3/2025***Additional consignees were sent URGENT: CLASS 1 RECALL letters due to additional affected units identified. Recommended Actions 1. Actions to Address the Issue During Use Note that only the devices listed in this letter are affected. No other products are involved in this action. Discontinue use of the affected device and proceed to the instructions for return of the device in Recommended Action below. 2. Actions to Correct the Issue Complete the attached Zyno Medical Z-800, Z-800F, Z-800W, and Z-800WF I

Distribution Pattern US Nationwide.

Code Information / Serial Numbers 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

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Medical Device Recall: Z-0005-2025

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer