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FDA (Device enforcement)Recalled 2020-10-08closedclass iii

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

Is my product affected?

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

  • UPC 20845357006213

Check against the official notice below — it lists the full affected range.

What happened

Microbiologics Inc. is recalling 187 units of KWIK-STIK 2 Pack Clostridium perfringens (Catalog Number 0318P, Lot Number 318-234-4). The foil pouch packaging for this lot contains an incorrect lot number printed on it—showing 218-234-4 instead of the correct 318-234-4. However, the correct lot number appears on both the KWIK-STIK canister label and the device label itself. The affected product was distributed throughout the United States and internationally to 33 countries including Canada, the United Kingdom, Japan, and others.

The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: 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 Quantity: 187 units Lot/code info: Catalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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