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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL Anaerobe CNA Agar with 5 Sheep Blood // Anaerobe Laked Sheep Blood KV Agar

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 Class 2 Device Recall BD BBL Anaerobe CNA Agar with 5 Sheep Blood // Anaerobe Laked Sheep Blood KV Agarsee related information
Date Initiated by FirmJune 06, 2013
Date PostedJuly 24, 2013
Recall Status1 Terminated 3 on September 03, 2013
Recall NumberZ-1801-2013
Recall Event ID 65614
510(K)NumberK803024 
Product Classification Culture media, selective and non-differential - Product Code JSJ
ProductBD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.
Code Information Lot 3080366 Exp 5/31/13 Lot 3071134 Exp 5/28/13 Lot 3081061 Exp 6/4/13
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information ContactMs. Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall		Microbiological identification media may exhibit reduced levels of Vancomycin.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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 Commerce106 cartons
DistributionWorldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JSJ
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