Device recall

Z-1632-2008: STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture…

FDA device recall · Class II · Advanced Sterilization Products

Key facts

Recall number (Z-number) Z-1632-2008
Recall event 47355
Product STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive reusable medical devices.
Product code MLR
Recalling firm Advanced Sterilization Products
Recall class Class II
Status Terminated
Termination date Nov 21, 2011
510(k) numbers K071385
FEI number 3003662624

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

Browse all FDA device recalls (products)