—#29083

Product

BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.

FDA product code: JSD — Culture Media, Selective Broth
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lot numbers: 3129508 exp 1/30/04 3129509 exp 2/3/04 3129506 exp 2/3/04 3129512 exp 2/3/04

Why it was recalled

Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Circle, Sparks, Maryland 21152

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2003-08-11
Posted by FDA: 2003-10-15
Terminated: 2003-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #29083. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.