Device recall

Z-1653-2022: Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code…

FDA device recall · Class I · Baxter Healthcare Corporation

Key facts

Recall number (Z-number) Z-1653-2022
Recall event 90730
Product Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Product code FPA
Recalling firm Baxter Healthcare Corporation
Recall class Class I
Status Terminated
Termination date Aug 9, 2024
510(k) numbers K112893
FEI number 1417572

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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)