| Class 2 Device Recall Difco Agar Noble, 500g bottle |  |
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
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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
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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 |
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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.
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