KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
FDA Recall Z-0581-2022 · Posted None
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Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeJTR
Date Initiated2020-10-08
Date Terminated2022-07-07
Product Quantity187 units
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.
Firm Action
Microbiologics notified customers on about 10/08/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions included the following:
1. REVIEW lab procedures to understand how this information affects your usage;
2. USE OR DISCARD depending on your lab procedures and how this information affects your usage;
3. COMPLETE the response form provided;
4. RETURN the response form to [email protected];
5. KEEP this letter for your records;
6. CONTACT Microbiologics if a replacement kit is needed.
Questions or concerns can be directed to Recall Support team at 320.229.7073 [email protected].
Root Cause
Employee error
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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