Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Low Volume Extension Set Recalled by Smiths Medical Asd Inc Due to Smiths Medical has become aware of an issue...

Date: May 4, 2015
Company: Smiths Medical Asd Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical Asd Inc directly.

Affected Products

Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

Quantity: 6,000 units

Why Was This Recalled?

Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.

Where Was This Sold?

This product was distributed to 5 states: KY, MN, NJ, UT, WI

Affected (5 states)Not affected

About Smiths Medical Asd Inc

Smiths Medical Asd Inc has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report