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FDA Device recall Z-0581-2022

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

On 2022-02-16 the FDA classified a Class III recall of KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) by Microbiologics, citing 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 correc….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0581-2022
ClassificationClass III
Statusterminated
Initiated2020-10-08
Published2022-02-16
Last updated2026-09-13 11:56 UTC
CompanyMicrobiologics
Distributionn/a

Product

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

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.

Identifiers

code_infoCatalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0581-2022%22

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