Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Difco Agar Noble, 500g bottle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Difco Agar Noble, 500g bottle see related information
Date Initiated by Firm October 03, 2017
Create Date March 09, 2018
Recall Status1 Terminated 3 on October 09, 2018
Recall Number Z-0935-2018
Recall Event ID 79217
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
Product Difco" Agar Noble, 500g bottle

Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required.
Code Information catalog number 214230, lot 7109502
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
Manufacturer Reason
for Recall		 HighPuragar was mislabeled and inadvertently sold as Noble Agar.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On October 3, 2017 an URGENT MEDICAL DEVICE PRODUCT RECA:LL letter was mailed to customers informing them of the recall and requesting that their inventory be checked for product, which should be quarantined and then thrown away. Also, to share notification of recall to any other customers that may have received product. Firm will replace any discarded inventory. Questions or concerns can be directed to: 1-800-638-8663.
Quantity in Commerce 216 bottles
Distribution USA (nationwide) Distribution to the states of and including Puerto Rico : AL, AZ, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA,TN, TX, UT, VA, WA
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.
-
-