FDA recall Z-0636-2022

Product

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

International distribution in the countries of Canada and Germany.

Key facts

Status

Terminated

Initiation date

2017-03-02

Report date

2022-02-16

Termination date

2022-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0636-2022