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Recall Observatory FDA recall evidence

Device product

SWIN 2017 database, Model YSW4000

Z-1939-2020

January 04, 2019

Class II

Product summary

Firm
Remel Inc.
Event
Event 84764
Status
Terminated
Classification
Class II
Quantity
250
Official record key
device-enforcement:Z-1939-2020

Official wording

Reason: Potential for out of range microbial results

Code information: ...

Distribution pattern: ...

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for out of range microbial results