Recall Z-0581-2022— Microbiologics Inc
Class III · Terminated
Class III FDA medical device recall by Microbiologics Inc, initiated 2020-10-08, terminated 2022-07-07. It names one FDA 510(k) clearance: K861022. 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..
- Recalling firm
- Microbiologics Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-10-08
- Terminated
- 2022-07-07
- Firm location
- Saint Cloud, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.