Recall Z-0511-2022— Microbiologics Inc

Name: FDA recall Z-0511-2022
Creator: U.S. Food and Drug Administration
Published: 2020-12-16

Class II · Terminated

Class II FDA medical device recall by Microbiologics Inc, initiated 2020-12-16, terminated 2022-07-07. It names one FDA 510(k) clearance: K861022. Product: KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.. Reason: Contamination with S. epidermidis.

Recalling firm: Microbiologics Inc
Classification: Class II
Status: Terminated
Initiated: 2020-12-16
Terminated: 2022-07-07
Firm location: Saint Cloud, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics·cleared 1986-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.