FDA Enforcement Class II Terminated

BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

Recall: Z-1805-2013 · Reported July 31, 2013

Enforcement

Recall Number
Z-1805-2013
Event ID
65614
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Becton Dickinson & Co.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
July 31, 2013
Initiation Date
June 6, 2013
Classification Date
July 24, 2013
Termination Date
September 3, 2013
Address
BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

Description

BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

Reason

Microbiological identification media may exhibit reduced levels of Vancomycin.

Code Info

Lot 3078430 Exp 5/30/13

Distribution

Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.

Quantity

293 cartons