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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV

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 Class 2 Recall
BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV
see related information
Date Posted July 24, 2013
Recall Status1 Terminated on September 03, 2013
Recall Number Z-1802-2013
Recall Event ID 65614
Premarket Notification
510(K) Number
Product Classification Culture Media, Selective And Differential - Product Code JSI
Product BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.
Code Information Lot 3071112 Exp 5/28/13
Recalling Firm/
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks, Maryland 21152-0999
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Gail Claiborne
Manufacturer Reason
for Recall
Microbiological identification media may exhibit reduced levels of Vancomycin.
FDA Determined
Cause 2
Action The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated June 2013 to Distributors by fax, US customers via letters by UPS and OUS BD sites via email and teleconference. The letter described the product, problem and actions to be taken. All customers were instructed to discontinue use of the listed product; discard any remaining packages, and complete and return the attached form, whether or not you have any inventory remaining, via Fax to: Attention: Regulatory Compliance, 410-316-4258. BD will issue replacements for the discarded material. It is not necessary to contact BD by telephone to receive replacements. If you have any questions, call 410-316-4000.
Quantity in Commerce 42 cartons
Distribution Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JSI and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC