FDA-Device2022-02-16Class III
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Microbiologics Inc
Hazard
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.
Sold states
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
Affected count
187 units
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0581-2022Don't want to check this manually?
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