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U.S. Department of Health and Human Services

Class 2 Device Recall Z800, Z800F, Z800W, and Z800WF Infusion Pumps

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 Class 2 Device Recall Z800, Z800F, Z800W, and Z800WF Infusion Pumpssee related information
Date Initiated by FirmJune 04, 2024
Date PostedJuly 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2263-2024
Recall Event ID 94768
510(K)NumberK130690 
Product Classification Pump, infusion - Product Code FRN
ProductZyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Code Information UDI-DI: Z800: 008143771020006 Z800F: 00814371020013 Z800W: 00814371020020 Z800WF: 00814371020037; Serial Numbers: Z-800: 905283 Z-800F: 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 Z-800W: 700568 Z-800WF: 503770 500010 500054 501954 502832 504296 504496 503950 500066
Recalling Firm/
Manufacturer		 Zyno Medical LLC
177 Pine St
Natick MA 01760-1331
For Additional Information ContactMatthew King
508-650-2008
Manufacturer Reason
for Recall		Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power.
FDA Determined
Cause 2		Process control
ActionAn URGENT: MEDICAL DEVICE CORRECTION notification letter dated 6/4/24 was sent to customers. Recommended Actions When using a system that has been identified as having the power supply module issue, keep them plugged into an external AC mains power source. 1. Actions to Address the Issue During Use Operate the unit on AC mains power source. If the affected system is disconnected from the external AC mains power source and the system presents an audible low battery alarm, re-connect the system to the external AC mains power source. If the affected system is disconnected from the external AC mains power source and immediately shuts down, re-connect to the external AC mains power source, and re-start the infusion therapy. If the system is turned on and it presents an audible low battery alarm prior to initiation of infusion therapy, proceed to a different system for the planned infusion therapy. Note that only the devices listed in this letter are affected. No other products are involved in this action. 2. Actions to Correct the Issue Complete the attached Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pump Power Supply Module 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. OTHER INFORMATION: " feedback@intuvie.com
Quantity in Commerce88 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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