Recall Z-1801-2013— Becton Dickinson & Co.

Name: FDA recall Z-1801-2013
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: K803024. Product: BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.. 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

K803024 — CDC ANAEROBE LAKED BL AGAR W/PARAMOMY.Bd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1980-12-22

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 Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.

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.