Becton Dickinson & Company
BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ
| Date | Jun 21, 2007 (initiated May 17, 2007) |
| Status | Terminated |
| Reason | Mislabeling : box and bag labels are incorrectly labeled to indicate the product contains Sodium Fluoride/Potassium Oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (Sodium Fluoride/Na2EDTA). |
| Root cause | Other |
| Action | Product Recall letters dated May 1, 2007. were sent to all distributors by first class mail. The letter requested all distributors to examine inventory for specific catalog and lot numbers. It also requested distributors to send a copy of the enclosed customer letter to all customers as a subrecall. BD has contracted a third party (West Inc., Appleton, Wisconsin) to coordinate the mailing to all customers, if the firm chooses to use the third party, or the distributor can send the letters themselves. |
| Quantity | 142,800 worldwide |
| Distribution | Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002456 | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 Becton Dickinson Vacutainer Systems, Nov 2, 2000 |