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Recall Observatory FDA recall evidence

Device product

The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

Z-1266-2016

January 13, 2016

Class II

Product summary

Firm
PMBS, LLC
Event
Event 73157
Status
Terminated
Classification
Class II
Quantity
58 units
Official record key
device-enforcement:Z-1266-2016

Official wording

Reason: Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.

Code information: ALL distributed S.C.O.R.E.S. units are affected.

Distribution pattern: FL, GA, MN, NY, OH, OR SC, and TN

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised sterility