Recall Z-0643-2010 ยท KZI Culture Media, Enriched
Becton Dickinson & Co.
BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled in part *** Becton Dickinson and Company, 7 Loveton Circle, Sparks, Maryland 21152 USA*** 800-638-8663 A general purpose liquid medium used for the cultivation of bacteria employed in the preparation of inocula for microdilution minimal inhibitory concentration (MIC) and identification (I
| Date | Jan 15, 2010 (initiated Feb 19, 2009) |
| Status | Terminated |
| Reason | In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms. |
| Root cause | Equipment maintenance |
| Action | The recalling firm notified direct accounts by an Urgent Product Recall letter on 02/19/09. The notification identified the affected product and stated the problem. The letter also advised that users discontinue use of the product and to discard any remaining packages. The attached response form should be completed and returned for replacement of product. If further assistance is needed regarding replacements, customers can contact BD Customer Service Department at 1-800-675-0908. |
| Quantity | 144 boxes |
| Distribution | Nationwide Distribution -- Including states of CA, CO, FL, GA, IL, MI, MN, MT, NY, OH, PA, TN, TX, UT, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.