Device recall

Z-0484-2009: STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use…

FDA device recall · Class II · Advanced Sterilization Products

Key facts

Recall number (Z-number) Z-0484-2009
Recall event 50071
Product STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical instruments.
Product code MLR
Recalling firm Advanced Sterilization Products
Recall class Class II
Status Terminated
Termination date Nov 7, 2011
510(k) numbers K042116
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

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