Recall Z-1282-2012 ยท JSC Culture Media, General Nutrient Broth
Becton Dickinson & Co.
Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 21030. Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms.
| Date | Mar 23, 2012 (initiated Feb 20, 2012) |
| Status | Terminated |
| Reason | In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended. |
| Root cause | Nonconforming Material/Component |
| Action | Becton Dickinson (BD) sent an "URGENT PRODUCT RECALL" letter dated February 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard any remaining affected product. BD will issue replacements for the discarded product. Additionally, an Acknowledgment Form was attached for customers to complete and return to the firm via fax to 410-316-4258. Contact BD Technical Services Department for questions regarding this notice. |
| Quantity | 6930 tubes |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Japan, Mexico, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.