Z-0739-2013Class II

BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and...

Name: Z-0739-2013 BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and...
Creator: Becton Dickinson & Co.
Published: 2012-12-10
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-12-10 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes... on 2012-12-10. FDA classified it as Class II and gives the reason as "Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0739-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-10
Posted: 2013-01-25
Terminated: 2013-07-01
Recalling firm: Becton Dickinson & Co
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.
Product code: JSC Culture Media, General Nutrient Broth
Reason for recall: Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
FDA root cause: Unknown/Undetermined by firm
Action: Becton Dickinson sent an Urgent Product Recall letter dated December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to discontinue use and discard any remaining product for replacement. Customers were also advised that due to an anticipated extended delay for the availability of Fildes Enrichment, BD will substitute DIFCO" Supplement B with Reconstituting Fluid as the replacement product. Customers were advised to ensure that this replacement product is appropriately validated in accordance with their laboratory's procedures. Customers with questions should contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4000.
Quantity in commerce: 11,710 tubes
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.
Product codes and lots: Lot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0739-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0739-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-25

Product code JSC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)