Recalls / —

—#106993

Product

BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications

FDA product code

FMI — Needle, Hypodermic, Single Lumen

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K021475

Affected lot / code info

Marketing Status: K021475 Device Listing Number: DQ41418 Reorder#300745, Lot#lll6090

Why it was recalled

Becton Dickinson has identified clogged needles.

Root cause (FDA determination)

Device Design

Action the firm took

Becton Dickinson sent Urgent Product Recall letters dated October 18, 2011 and October 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to deterine if they have any of the affected product. If they have affected product customers should return the product to Beckton Dickinson. For any questions regarding this recall call 201-847-4344.

Recalling firm

Firm

Becton Dickinson & Company

Address

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

Distribution

Distribution pattern

Nationwide Distribution including IL and NJ

Timeline

Recall initiated

2011-10-08

Posted by FDA

2012-02-13

Terminated

2012-12-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #106993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.