—#50968

Product

BD 30ml Syringe Luer-Lok tip Sterile BD, Franklin Lakes, NJ Made in USA

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K980987
Affected lot / code info: Reorder number 309650 Lot numbers 6188613, 6188614

Why it was recalled

The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.

Root cause (FDA determination)

Other

Action the firm took

Distributors were sent recall notification letters on February 1, 2007 Recall notification letters were sent to all direct accounts and potential end users via UPS second day air on February 15, 2007.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-02-15
Posted by FDA: 2007-04-05
Terminated: 2007-07-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50968. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.