Recall Z-1802-2013— Becton Dickinson & Co.

Name: FDA recall Z-1802-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-06

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2013-06-06, terminated 2013-09-03. It names one FDA 510(k) clearance: K832955. Product: BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.. Reason: Microbiological identification media may exhibit reduced levels of Vancomycin..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2013-06-06
Terminated: 2013-09-03
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K832955 — BACTEROIDES BILE ESCULIN AGARBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1983-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.

Reason for recall

Microbiological identification media may exhibit reduced levels of Vancomycin.

Data sourced from openFDA. This site is unofficial and independent of the FDA.