—#66591

Product

BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K011984
Affected lot / code info: Lot #'s : 7117874, 7157882, 7159943, 7180478, 7215299, 7215300, 7324340, and 7234341.

Why it was recalled

Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174

Recalling firm

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

Distribution

Distribution pattern: Worldwide-USA and Canada

Timeline

Recall initiated: 2007-11-20
Posted by FDA: 2008-01-23
Terminated: 2008-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66591. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.