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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 August 11, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on November 19, 2003
Recall Number Z-1294-03
Recall Event ID 27049
Product Classification Culture Media, Selective Broth - Product Code JSD
Product BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
Code Information Lot numbers: 3129508 exp 1/30/04 3129509 exp 2/3/04 3129506 exp 2/3/04 3129512 exp 2/3/04
Recalling Firm/
Becton Dickinson & Co.
7 Loveton Circle
Sparks MD 21152
For Additional Information Contact Regulatory Compliance
Manufacturer Reason
for Recall
Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.
FDA Determined
Cause 2
Action Recalling firm notified distributors and end user by letter 8/11/03 and advised of product failure. Consignees were requested to discontinue distribution and use and discard product for replacment. Consignees were requested to return response form.
Quantity in Commerce 860 cartons
Distribution Product was sold to 11 distributors and one end user in the US. Product was additionally distributed to firm''s subsidiaries in Canada and Europe.
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.