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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 28, 2005
Date Posted August 31, 2005
Recall Status1 Terminated 3 on October 17, 2005
Recall Number Z-1458-05
Recall Event ID 32943
Product Classification Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth - Product Code JTZ
Product Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.
Code Information Lot #5140549, EXP 8/17/05
Recalling Firm/
Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact BD Customer Service
Manufacturer Reason
for Recall
Microbiological media for antibiotic susceptibility testing gives false test results.
FDA Determined
Cause 2
Action The recalling firm notified distributors and direct accounts by fax, e-mail, and letters on 07/28/2005. The notifications advised of false resistant results with control organisms known to be oxcacillin susceptible. Customers were instructed to discontinue use of the lot and discard for replacement. Distributors were requested to discontinue distribution and provide consignee list for subsequent notification. Response forms are included with the recall letters.
Quantity in Commerce 20930 plates
Distribution Product was sold to distributors and direct account end-users worldwide including government facilities.
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.