Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity...

FDA Device Recall #Z-2894-2016 — Class II — July 29, 2016

Recall Summary

Recall Number Z-2894-2016
Classification Class II — Moderate risk
Date Initiated July 29, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zyno Medical LLC
Location Natick, MA
Product Type Devices
Quantity 78069 sets

Product Description

Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.

Reason for Recall

Administration Set potential filter leaking

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

Lot Code: 14015257 14016574 14026116 14055563 14056558 14056578 14056564 14097009 14105233 14105981 14106122 14115694 14116060 14116061 15035164 15036531 15036532 15066217 15086619 15096764 15096765 15096843 15105499

Other Recalls from Zyno Medical LLC

Recall # Classification Product Date
Z-1868-2025 Class I Z-800WF Infusion System. Intended to provide in... May 7, 2025
Z-1866-2025 Class I Z-800F Infusion System. Intended to provide int... May 7, 2025
Z-1867-2025 Class I Z-800W Infusion System. Intended to provide int... May 7, 2025
Z-1865-2025 Class I Z-800 Infusion System. Intended to provide intr... May 7, 2025
Z-0506-2025 Class II Z-800 Infusion System. Model/Catalog Number: Z-... Oct 18, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.