BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Di
FDA device recall Z-0957-2007 · posted 2007-06-21 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 142,800 worldwide
- Distribution
- Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia
- Date initiated
- 2007-05-17
- Date posted
- 2007-06-21
- Date terminated
- 2007-08-15
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 (K002456) | Becton Dickinson Vacutainer Systems | 2000-11-02 |