Recall Z-2542-2014 ยท JCF Lymphocyte Separation Medium
Becton Dickinson & Company
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
| Date | Aug 22, 2014 (initiated Jul 3, 2014) |
| Status | Terminated |
| Reason | BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells. |
| Root cause | Under Investigation by firm |
| Action | BD issued an "Urgent Voluntary Product Recall" Letter dated July 3, 2014 and a "Notice of Return" Form to all affected customers. |
| Quantity | 296,160 tubes |
| Distribution | US and Foreign |
| FDA record | Open on fda.gov |