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Recall Observatory FDA recall evidence

Device product

STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.

Z-0998-2013

March 13, 2012

Class II

Product summary

Firm
Advanced Sterilization Products
Event
Event 64609
Status
Terminated
Classification
Class II
Quantity
2,457 units
Official record key
device-enforcement:Z-0998-2013

Official wording

Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.

Code information: Unavailable

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.