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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL Schaedler KV Agar with 5 Sheep Blood

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 Class 2 Recall
BD BBL Schaedler KV Agar with 5 Sheep Blood
see related information
Date Posted July 24, 2013
Recall Status1 Terminated on September 03, 2013
Recall Number Z-1799-2013
Recall Event ID 65614
Premarket Notification
510(K) Number
K760460 
Product Classification Culture Media, Selective And Non-Differential - Product Code JSJ
Product BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
Code Information Lot 3078263 Exp 5/16/13
Recalling Firm/
Manufacturer
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
410-316-4054
Manufacturer Reason
for Recall
Microbiological identification media may exhibit reduced levels of Vancomycin.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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 92 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 = JSJ and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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