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Recall Observatory FDA recall evidence

Device product

KWIK-STIK" plus: Clostridium perfringens

Z-1125-2022

May 06, 2022

Class III

Product summary

Firm
Microbiologics Inc
Event
Event 90150
Status
Terminated
Classification
Class III
Quantity
8 units
Official record key
device-enforcement:Z-1125-2022

Official wording

Reason: Labeling error.

Code information: catalog number: 0801P; lot number: 801-44-4; expiration date: 05/31/2023; UDI: 20845357019374

Distribution pattern: Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling error