Device recall

Z-0351-04: Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU

FDA device recall · Class II · Toray Marketing & Sales (America), Inc

Key facts

Recall number (Z-number) Z-0351-04
Recall event 28027
Product Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU
Product code FJI
Recalling firm Toray Marketing & Sales (America), Inc
Recall class Class II
Status Terminated
Termination date Feb 3, 2004
510(k) numbers K935471
FEI number 3001632632

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)