Z-0209-2018Class II

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

Name: Z-0209-2018 CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres
Creator: Remel Inc
Published: 2017-11-02
License: https://open.fda.gov/license/

Remel Inc / initiated 2017-11-02 / Terminated / root cause: labeling and UDI

FDA source

Remel Inc began a recall of CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres on 2017-11-02. FDA classified it as Class II and gives the reason as "Product may have incorrect cation information detailed on the product label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0209-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-02
Posted: 2017-12-07
Terminated: 2020-08-05
Recalling firm: Remel Inc
Product: CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
Product code: JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Reason for recall: Product may have incorrect cation information detailed on the product label.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 11/2/2017 via regular mail on 11/2/2017 notifying the customer of the incorrect labeling information and providing them the correct labeling information.
Quantity in commerce: 7 units
Distribution: Distribution was made to AL, MD, ME, NC, and TN. There was no foreign/military/government distribution.
Product codes and lots: Lot 1865331, Exp. 06/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0209-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0209-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-07

Product code JTZ

K802498Class IIMueller Hinton AgarOxoid U.S.A., Inc. / cleared 1980-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)