BBL — Class II medical device recall Z-0739-2013
Terminated recall by Becton Dickinson & Co., reported 2013-02-06, distributed nationwide. Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth
| Recall number | Z-0739-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2012-12-10 |
| Classified | 2013-01-25 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2013-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, HK, JP, KR, MX, SG, TW |
| Quantity | 11,710 tubes |
| Reason classes | device malfunction |
| Lot numbers | 2079066, 2096375, 2216092, 2227271 |
| Model numbers | 211866 |
| Expiration dates | 2013-03-06, 2013-03-22, 2013-07-20 |
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 for recall
Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.