Device recall

Z-0181-2023: NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon…

FDA device recall · Class II · Fresenius Medical Care Holdings, Inc.

Key facts

Recall number (Z-number) Z-0181-2023
Recall event 90947
Product NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Product code KPO
Recalling firm Fresenius Medical Care Holdings, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K070177
FEI number 3001451489

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)