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U.S. Department of Health and Human Services

Class 2 Device Recall CM0405 MuellerHinton Broth IVD

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  Class 2 Device Recall CM0405 MuellerHinton Broth IVD see related information
Date Initiated by Firm November 02, 2017
Create Date December 07, 2017
Recall Status1 Terminated 3 on August 05, 2020
Recall Number Z-0209-2018
Recall Event ID 78470
510(K)Number K802498  
Product Classification Culture media, antimicrobial susceptibility test, mueller hinton agar/broth - Product Code JTZ
Product CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
Code Information Lot 1865331, Exp. 06/2021
Recalling Firm/
Manufacturer
Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Gary Klaassen
913-895-4077
Manufacturer Reason
for Recall
Product may have incorrect cation information detailed on the product label.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JTZ and Original Applicant = OXOID U.S.A., INC.
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