Device recall

Z-1056-2017: APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the…

FDA device recall · Class II · Baxter Healthcare Corporation

Key facts

Recall number (Z-number) Z-1056-2017
Recall event 75998
Product APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
Product code FKX
Recalling firm Baxter Healthcare Corporation
Recall class Class II
Status Terminated
Termination date Aug 24, 2017
510(k) numbers K102936
FEI number 1417572

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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

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