—#101790

Product

BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system.

FDA product code: KST — System, Blood Collection, Vacuum-Assisted, Manual
Device class: Class 1
Medical specialty: Hematology
Affected lot / code info: Catalog # 367324, Lot #0315173, 0316102, 0323342, 0327441, and 1025938; Catalog # 367326, Lot #0309244, 0309286, and 0312571; Catalog #367344, Lot #0334101, 0336557, 0347425, 0354635, and 10131090.

Why it was recalled

BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.

Root cause (FDA determination)

Device Design

Action the firm took

BD Diagnostics sent a "Lot Specific Product Recall" letter dated April 22, 2011 to all affected customers. The letter asked customers return any affected product and provides instructions for its return. The letter ask customers return the attached Packaging List with the shipment. For question on this recall contact BD Diagnostics at (201) 847-5117.

Recalling firm

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

Distribution

Distribution pattern: Nationwide (USA) Distribution.

Timeline

Recall initiated: 2011-04-22
Posted by FDA: 2011-08-16
Terminated: 2012-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101790. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.