Z-0636-2022 Class III Terminated
FDA device recall Z-0636-2022 was initiated by Microbiologics Inc on March 2, 2017 and is designated Class III. Reason for recall: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. The recall status is terminated (terminated April 22, 2022). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- March 2, 2017
- Termination Date
- April 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.
Reason for Recall
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Distribution Pattern
International distribution in the countries of Canada and Germany.
Code Information
Catalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701