Device recall

Z-0741-2012: STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical…

FDA device recall · Class II · Advanced Sterilization Products

Key facts

Recall number (Z-number) Z-0741-2012
Recall event 60889
Product STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer 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 Sep 23, 2013
510(k) numbers K030429
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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