Class 2 Device Recall CM0405 MuellerHinton Broth IVD

• Date Initiated by Firm: November 02, 2017
• Create Date: December 07, 2017
• Recall Status: Terminated 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: 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