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U.S. Department of Health and Human Services

Class 2 Device Recall BBL MartinLewis Agar

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  Class 2 Device Recall BBL MartinLewis Agar see related information
Date Initiated by Firm March 17, 2021
Create Date April 08, 2021
Recall Status1 Terminated 3 on August 05, 2022
Recall Number Z-1378-2021
Recall Event ID 87546
510(K)Number K770287  
Product Classification Culture media, for isolation of pathogenic neisseria - Product Code JTY
Product BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi.
Catalog Number: 221557
Code Information Lot Number: 0317558, Exp. Date 2021-MAR-11 UDI:  (01)30382902215579 (10)0317558(17)031121 (30)0020
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact SAME
410-316-4000
Manufacturer Reason
for Recall		 Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment
FDA Determined
Cause 2		 Under Investigation by firm
Action BD issued Urgent Medical Device Correction letter on 3/17/21 to customers and distributors via FedEx tracked letter. Letter states reason for recall, health risk and action to take: 1.Immediately inspect your inventory for the specific catalog and lot numbers listed above. Destroy all products subject to the recall following your institutions process for destruction. 2.Share this recall notification with all users within your facility network to ensure they are also aware of this recall. 3.Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement, if required. BD will provide a product replacement for all destroyed inventory. If you require further assistance, please contact: BD Contact US Contact Information Outside of US BD Customer/ Technical Support 800-638-8663 Monday  Friday 7:00am and 7:00pm EST For customers outside the US, contact the local BD representative or distributor.
Quantity in Commerce 33660 EA
Distribution Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.
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 = JTY and Original Applicant = GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
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