Z-0544-2022 Class III Terminated
FDA device recall Z-0544-2022 was initiated by Microbiologics Inc on February 24, 2021 and is designated Class III. Reason for recall: Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. The recall status is terminated (terminated July 11, 2022). Affected quantity: 47 packs (94 units).
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- February 24, 2021
- Termination Date
- July 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 packs (94 units)
Product Description
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Reason for Recall
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Distribution Pattern
US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.
Code Information
Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381