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Z-0739-2013 Class II Terminated

Recalled by Becton Dickinson & Co. — Sparks, MD

FDA device recall Z-0739-2013 was initiated by Becton Dickinson & Co. on Dec 10, 2012 and is designated Class II. Reason for recall: Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species. The recall status is terminated (terminated Jul 1, 2013). Affected quantity: 11,710 tubes.

Recall Details

Product Type: Devices
Report Date: Feb 6, 2013
Initiation Date: Dec 10, 2012
Termination Date: Jul 1, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,710 tubes

Product Description

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 for Recall

Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.

Code Information

Lot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0739-2013
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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