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Recall Observatory FDA recall evidence

Device product

KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)

Z-0581-2022

October 08, 2020

Class III

Product summary

Firm
Microbiologics Inc
Event
Event 89386
Status
Terminated
Classification
Class III
Quantity
187 units
Official record key
device-enforcement:Z-0581-2022

Official wording

Reason: The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.

Code information: Catalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213

Distribution pattern: US distribution to . International distribution to Austria, Botswana, Brazil, Canada, China, Colombia, Finland, France, Germany, Guatemala, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Malaysia, Mauritius, Netherlands, Norway, Oman, Peru, Poland, Romania, South Africa, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.