Recall Z-0209-2018— Remel Inc

Name: FDA recall Z-0209-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-02

Class II · Terminated

Class II FDA medical device recall by Remel Inc, initiated 2017-11-02, terminated 2020-08-05. It names one FDA 510(k) clearance: K802498. Product: CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.. Reason: Product may have incorrect cation information detailed on the product label..

Recalling firm: Remel Inc
Classification: Class II
Status: Terminated
Initiated: 2017-11-02
Terminated: 2020-08-05
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K802498 — MUELLER HINTON AGAROxoid U.S.A., Inc.·cleared 1980-11-12

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

CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.

Reason for recall

Product may have incorrect cation information detailed on the product label.

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