Device recall

Z-0033-2024: 2008T HD SYS. CDX W/BIBAG BLUESTAR

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

Key facts

Recall number (Z-number) Z-0033-2024
Recall event 92788
Product 2008T HD SYS. CDX W/BIBAG BLUESTAR
Product code KDI
Recalling firm Fresenius Medical Care Holdings, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K150708, K173972, K222952
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)