Medical device lot number misprinted on packaging
Microbiologics Inc recalls KWIK-STIK 2 Pack Clostridium perfringens reference material (lot 318-234-4) because the foil pouch shows incorrect lot number 218-234-4. The correct number is on the device label.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving a lot number printing error on product packaging. The correct lot number remains visible on the device itself. No reported illnesses, injuries, or safety incidents. Per the rubric, packaging-only and documentation issues typically warrant a Low severity rating.
Plain-English summary
Microbiologics Inc is recalling KWIK-STIK 2 Pack Clostridium perfringens (catalog number 0318P, lot 318-234-4, UDI 20845357006213) due to a printing error on the foil pouch packaging. All 187 affected units have the lot number printed incorrectly as 218-234-4 on the pouch, while the correct lot number (318-234-4) is clearly printed on both the KWIK-STIK canister label and the device label.
This recall affects units distributed within the United States and internationally to 35 countries including Austria, Brazil, Canada, China, France, Germany, India, Japan, Korea, and others.
Customers who have received affected units should note that the correct lot number is available on the canister and device labels themselves. No adverse events or safety incidents related to this labeling discrepancy have been reported.
The recalled product
- Product
- KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
- Manufacturer
- Microbiologics Inc
- Hazard
- lot-number-mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog Number : 0318P
- Lot Number: 318-234-4
- UDI: 20845357006213
Distribution
Distribution scope not specified by the agency.
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