Recall Z-0739-2013— Becton Dickinson & Co.

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2012-12-10, terminated 2013-07-01. FDA's recall record names no specific 510(k) clearance for this event. Product: BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (nicotinamide adenine dinucleotide, NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use.. Reason: Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species..

Recalling firm

Becton Dickinson & Co.

Classification

Class II

Status

Terminated

Initiated

2012-12-10

Terminated

2013-07-01

Firm location

Sparks, MD, United States

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