Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0164-04

Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog...

Becton Dickinson & Co / initiated 2003-10-10 / Terminated

Becton Dickinson & Co began a recall of Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per... on . The reason FDA records is "Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0164-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per carton.
Product code
JTY Culture Media, For Isolation Of Pathogenic Neisseria
Reason for recall
Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species.
FDA root cause
Other
Action
The recalling firm notified distributors by fax and end users by certified mail on 10/10/03. The recall notice advised consignees of reduced growth of Haemophilus species, and instructed them to discontinue distribution and use and discard product for replacement. The letter requests consignees to respond with replacement units needed.
Quantity in commerce
7302 cartons
Distribution
Product was sold to domestic distributors and direct shipped end users nationwide including government consignees, and was additionally sold to affiliated international distributors.
Product codes and lots
Lot/EXP 3197678/ November 13, 2003*** 3197693/ November 14, 2003*** 3198565/ November 07, 2003*** 3212853/ November 25, 2003*** 3212901/ November 27, 2003*** 3212919/ November 28, 2003*** 3212956/ December 02, 2003*** 3212972/ December 03, 2003***