Z-0511-2022 Class II Terminated
FDA device recall Z-0511-2022 was initiated by Microbiologics Inc on December 16, 2020 and is designated Class II. Reason for recall: Contamination with S. epidermidis The recall status is terminated (terminated July 7, 2022). Affected quantity: 59 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 26, 2022
- Initiation Date
- December 16, 2020
- Termination Date
- July 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 kits
Product Description
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Reason for Recall
Contamination with S. epidermidis
Distribution Pattern
Distribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and WV. There was no government/military distribution. Foreign distribution was made to Brazil, Canada, Colombia, Dominican Republic, Finland, France, India, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Saudi Arabia, Serbia, South Africa, and United Kingdom.
Code Information
KWIK-STIK 2 Pack - Catalog#: 0894P, Lot #: 894-68-3, Exp. 6/30/2022, 894-68-4, Exp. 6/30/2022, UDI: 20845357022947; KWIK-STIK 6 Pack - Catalog#: 0894K, Lot #: 894-68-1, Exp. 6/30/2022, UDI: 30845357022951; LYFO DISK - Catalog#: 0894L, Lot #: 894-68-2, Exp. 6/30/2022, UDI: 10845357022964;