Device recall

Z-0080-2015: 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets…

FDA device recall · Class II · Baxter Healthcare Corp

Key facts

Recall number (Z-number) Z-0080-2015
Recall event 69253
Product 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Product code KDJ
Recalling firm Baxter Healthcare Corp
Recall class Class II
Status Terminated
Termination date Jan 4, 2016
510(k) numbers K791899
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

Browse all FDA device recalls (products)