Recalls / —

—#25313

Product

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

FDA product code

JTY — Culture Media, For Isolation Of Pathogenic Neisseria

Device class

Class 2

Medical specialty

Microbiology

Affected lot / code info

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

Why it was recalled

Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Becton Dickinson & Co.

Address

7 Loveton Circle, Sparks, Maryland 21152

Distribution

Distribution pattern

Product was sold to distributors and subsequently distributed to medical facility end users nationwide and internationally.

Timeline

Recall initiated

2002-11-18

Posted by FDA

2002-12-18

Terminated

2003-05-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25313. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.