Recall Z-0196-2018— Becton Dickinson & Co.

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2017-05-22, terminated 2018-02-26. FDA's recall record names no specific 510(k) clearance for this event. Product: TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.. Reason: Listeria monocytogenes contamination of non-sterile plated media.

Recalling firm
Becton Dickinson & Co.
Classification
Class II
Status
Terminated
Initiated
2017-05-22
Terminated
2018-02-26
Firm location
Sparks, MD, United States

Product description

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.

Reason for recall

Listeria monocytogenes contamination of non-sterile plated media

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