Device recall

Z-0194-2016: Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

FDA device recall · Class II · Baxter Healthcare Corp.

Key facts

Recall number (Z-number) Z-0194-2016
Recall event 72362
Product Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Product code KDJ
Recalling firm Baxter Healthcare Corp.
Recall class Class II
Status Terminated
Termination date Jun 27, 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

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