Recalls / —

—#39082

Product

Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238

FDA product code

FMI — Needle, Hypodermic, Single Lumen

Device class

Class 2

Medical specialty

General Hospital

Affected lot / code info

Lot Number: K621494

Why it was recalled

Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"

Root cause (FDA determination)

Other

Action the firm took

Smith Medical notified dealers of the recall on May 5, 2005 by telephone. The remaining customers were notified on May 12, 2005 by telephone. Follow-up letter delivered by Federal Express on May 17, 2005.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2005-05-05

Posted by FDA

2005-06-01

Terminated

2012-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #39082. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.