Device recall

Z-1269-2015: MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

FDA device recall · Class II · Baxter Healthcare Corp.

Key facts

Recall number (Z-number) Z-1269-2015
Recall event 70512
Product MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Product code KDI
Recalling firm Baxter Healthcare Corp.
Recall class Class II
Status Completed
510(k) numbers K895631
FEI number 1417572

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)