—#75048

Product

BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.

FDA product code: MEG — Syringe, Antistick
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K023752
Affected lot / code info: Lot number 8078251

Why it was recalled

Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

Recall letters were sent on November 24, 2008 to all direct customers and potential end users of the product by UPS second day air. BD requests that inventory be examined and affected product be quarantined and returned as per recall letter instructions. Questions should be directed to BD customer service at 888-237-2762, M-F 8.OO AM to 5:00 PM EST.

Recalling firm

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

Distribution

Distribution pattern: GA, KS, OH, MO, FL, PA, KY and NY.

Timeline

Recall initiated: 2008-11-24
Posted by FDA: 2009-01-13
Terminated: 2009-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75048. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.