FDA Device recall Z-0739-2013
BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** I…
- FDA Device
- Class II
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class II recall of BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** I… by Becton Dickinson And, citing enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0739-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-10 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
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.
Identifiers
| code_info | Lot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0739-2013%22
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