Recall Z-0739-2013 ยท JSC Culture Media, General Nutrient Broth
Becton Dickinson & Co.
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
| Date | Jan 25, 2013 (initiated Dec 10, 2012) |
| Status | Terminated |
| Reason | Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species. |
| 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 |
| Quantity | 11,710 tubes |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.