—#52337

Product

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

510(k) numbers: K002456
Affected lot / code info: Catalog Number 365992 Lot numbers: 6139630, 6213209, 6296815 and 7059245

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia

Timeline

Recall initiated: 2007-05-17
Posted by FDA: 2007-06-21
Terminated: 2007-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52337. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.