Recalls / —

—#67218

Product

BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, BD, Franklin Lakes, NJ 07417.

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

Affected lot / code info

Reorder number: 3039605; Lot numbers 7061015, 7061014, 7092726, 7094789, 7094790, 7123223, 7123225, 7150947, 7150949, 7184442, 7184443, 7184446, 7212935, 7239568, 7239570, 7239569, 7271873.

Why it was recalled

Defective Seal: The convenience trays may have open seals, which can adversely impact tray sterility.

Root cause (FDA determination)

Packaging

Action the firm took

BD notified distributors by an Urgent Product Recall Letter sent via UPS on January 7, 2008. In addition, the firm sent an Urgent Product Recall Letter on January 11, 2008 to customers identified by the distributors. The letter instructed the users to remove the product from its inventory and to return affected products to the firm using an enclosed customer packing list. For additional information, contact 1-888-237-2762.

Recalling firm

Firm

Becton Dickinson & Company

Address

1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern

Nationwide, including the states of CA, NY, MO, MA, IL, OH, TN, TX, MI, LA, MO, ID, GA, NE, SC and FL.

Timeline

Recall initiated

2008-01-07

Posted by FDA

2008-04-16

Terminated

2008-05-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #67218. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.