Summary
The FDA issued a Class II for Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps by Zyno Medical LLC. Reason: 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 rechar.
Details
Source
Device Recall
External ID
Z-2263-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Lot/Code Info: 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
Quantity Affected: 88 units
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-04
Company
Natick, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zyno Medical LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zyno Medical LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zyno Medical LLC have FDA actions?
Zyno Medical LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2263-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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