Device recall

Z-1183-2024: Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous…

FDA device recall · Class II · Zyno Medical LLC

Key facts

Recall number (Z-number) Z-1183-2024
Recall event 93857
Product Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Product code FRN
Recalling firm Zyno Medical LLC
Recall class Class II
Status Open, Classified
510(k) numbers K130690
FEI number 3006575795

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)