Z-2263-2024 Class II Ongoing

Recalled by Zyno Medical LLC — Natick, MA

Recall Details

Product Type
Devices
Report Date
July 10, 2024
Initiation Date
June 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
88 units

Product Description

Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps

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 Pattern

US Nationwide distribution.

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