Device recall

Z-0695-2007: Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700…

FDA device recall · Class II · Gambro Renal Products, Inc.

Key facts

Recall number (Z-number) Z-0695-2007
Recall event 37306
Product Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
Product code KDI
Recalling firm Gambro Renal Products, Inc.
Recall class Class II
Status Terminated
Termination date Jan 3, 2012
510(k) numbers K041005
FEI number 1713683

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)