Recalls / —

—#33843

Product

Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313

FDA product code

FMI — Needle, Hypodermic, Single Lumen

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K011925

Affected lot / code info

Lot Number: K527299

Why it was recalled

Sterility of product is not assured

Root cause (FDA determination)

Other

Action the firm took

Smiths Medical notified consignees by telephone on June 29, 2004. The consignees were asked to immediately quarantine their stock . The Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2004-06-29

Posted by FDA

2004-07-20

Terminated

2006-05-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #33843. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.