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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Zyno Medical LLC: Z800 Series Infusion Pumps Recalled for Faulty Power Supply Modules

Agency Publication Date: July 3, 2024
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Summary

Zyno Medical LLC has recalled 88 units of their Z800, Z800F, Z800W, and Z800WF Infusion Pumps because the power supply modules may be faulty. This defect prevents the module from charging the pump's internal battery, which could result in the device having insufficient or no power when it is unplugged from a wall outlet. These infusion pumps were distributed nationwide across the United States. Consumers should contact their healthcare provider or the manufacturer to address this issue.

Risk

If the pump is disconnected from AC mains power, a faulty power supply module may leave the device with no battery backup, causing the pump to stop delivering critical fluids or medications. This sudden interruption of therapy could lead to serious health complications depending on the patient's condition and the medication being administered.

What You Should Do

  1. Check your infusion pump to determine if it is one of the affected models: Z800, Z800F, Z800W, or Z800WF.
  2. Verify if your device's serial number is included in the recall. Affected Z800 serial numbers include 905283. Z-800F serial numbers include 610844, 609115, 616225, 608843, 608854, 608878, 609662, 611192, 611221, 605032, 607483, 613133, 619542, 609315, 607545, 602521, 611251, 601782, 601905, 604576, 602023, 604135, 601424, 602518, 608407, 608335, 608361, 608399, 608438, 607773, 608590, 609773, 608955, 608960, 608962, 610650, 607324, 610217, 607402, 608152, 608197, 609143, 609380, 608996, 607439, 611588, 611605, 614257, 609672, 609730, 601191, 614278, 608497, 608641, 610128, 610132, 610158, 601438, 615722, 616791, 603717, 607171, 608826, 608150, 608137, 609199, 609276, 602280, 610713, 613781, 607496, 608918, 609355, 605090, 608790, 603096, and 615110. Z-800W serial number includes 700568. Z-800WF serial numbers include 503770, 500010, 500054, 501954, 502832, 504296, 504496, 503950, and 500066.
  3. Check the UDI-DI on the device labeling: Z800 (008143771020006), Z800F (00814371020013), Z800W (00814371020020), or Z800WF (00814371020037).
  4. Ensure the pump remains plugged into AC mains power (a wall outlet) at all times to prevent power failure until the device is serviced.
  5. Contact Zyno Medical LLC or your healthcare provider immediately for instructions on how to receive a repair or replacement for the faulty power supply module.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer for instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Zyno Medical Z800 Infusion Pump
Model / REF:
Z800
UPC Codes:
008143771020006
Lot Numbers:
Serial Number: 905283
Product: Zyno Medical Z800F Infusion Pump
Model / REF:
Z800F
UPC Codes:
00814371020013
Lot Numbers:
Serial Numbers: 610844 609115 616225 608843 608854 608878 609662 611192 611221 605032 607483 613133 619542 609315 607545 602521 611251 601782 601905 604576 602023 604135 601424 602518 608407 608335 608361 608399 608438 607773 608590 609773 608955 608960 608962 610650 607324 610217 607402 608152 608197 609143 609380 608996 607439 611588 611605 614257 609672 609730 601191 614278 608497 608641 610128 610132 610158 601438 615722 616791 603717 607171 608826 608150 608137 609199 609276 602280 610713 613781 607496 608918 609355 605090 608790 603096 615110
Product: Zyno Medical Z800W Infusion Pump
Model / REF:
Z800W
UPC Codes:
00814371020020
Lot Numbers:
Serial Number: 700568
Product: Zyno Medical Z800WF Infusion Pump
Model / REF:
Z800WF
UPC Codes:
00814371020037
Lot Numbers:
Serial Numbers: 503770 500010 500054 501954 502832 504296 504496 503950 500066

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94768
Status: Active
Manufacturer: Zyno Medical LLC
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 88 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.