Device recall

Z-0790-05: Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer…

FDA device recall · Class II · Asahi Medical Co Ltd

Key facts

Recall number (Z-number) Z-0790-05
Recall event 31536
Product Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation…
Product code KDI
Recalling firm Asahi Medical Co Ltd
Recall class Class II
Status Terminated
Termination date Jul 10, 2006
510(k) numbers K001250
FEI number 3002806407

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)