Enforcement Report - Week of February 6, 2013
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Product Detail
| 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. |
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| Recall Number | Z-0739-2013 |
| Classification | Class II |
| Code Info | Lot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013 |
| Product Distributed Qty | 11,710 tubes |
| Reason For Recall | Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species. |
Event Detail
| Event Id | 64008 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Becton Dickinson & Co. |
| City | Sparks |
| State | MD | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-10 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore. |
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