Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0345-03

Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. Catalog # 221267

Becton Dickinson & Co / initiated 2002-11-18 / Terminated

Becton Dickinson & Co. began a recall of Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. Catalog # 221267 on . The reason FDA records is "Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0345-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. Catalog # 221267
Product code
JTY Culture Media, For Isolation Of Pathogenic Neisseria
Reason for recall
Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.
FDA root cause
Other
Action
Becton Dickinson notified distributors by fax on 11/18/02 to discard inventory. Firm additionally notified distributors on 11/21/02 to include three additional lots of agar for recall. End users were notified by letter 11/21/02 to discard inventory for replacement, and return reply form.
Quantity in commerce
6422 cartons/ 100 plates per carton
Distribution
Product was sold to distributors and subsequently distributed to medical facility end users nationwide and internationally.
Product codes and lots
Lots: 2213201 EXP 11/25/02 2213211 EXP 11/26/02 2261524 EXP 1/14/02 2246310 EXP 1/1/03 2261552 EXP 1/15/03 2276445 EXP 1/29/03