Class 2 Device Recall

• Date Initiated by Firm: August 11, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated 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/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Circle; Sparks MD 21152
• For Additional Information Contact: Regulatory Compliance; 410-316-4258
• 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: Other
• 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.