—#52131

Product

BD AutoShield Pen Needle (Re order Number : 329300)

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K060007
Affected lot / code info: Reorder Number 329300

Why it was recalled

Needle Sticks: Complaints were received regarding Needle Stick Injuries while administering insulin to patients. (Labeling will be revised to provide clear direction on product usage)

Root cause (FDA determination)

Other

Action the firm took

April 23, 2007, Recall letters were sent via UPS 2nd day air and/or hand delivered to all direct consignees and potential customers of the product.

Recalling firm

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

Distribution

Distribution pattern: Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.

Timeline

Recall initiated: 2007-04-23
Posted by FDA: 2007-05-24
Terminated: 2008-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52131. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.