Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1294-03

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

Becton Dickinson & Co / initiated 2003-08-11 / Terminated

Becton Dickinson & Co. began a recall of BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266 on . The reason FDA records is "Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1294-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
Product code
JSD Culture Media, Selective Broth
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 root 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.
Product codes and lots
Lot numbers: 3129508 exp 1/30/04 3129509 exp 2/3/04 3129506 exp 2/3/04 3129512 exp 2/3/04