Class II — Potential Health Hazard

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

Portex¿ Spinal Tray with Drugs 25g Whitacre Recalled by Smiths Medical ASD, Inc. Due to Visual particulate in the glass ampules of 5%...

Date: September 23, 2013
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

Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.

Quantity: 3980

Why Was This Recalled?

Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc. has 114 total recalls tracked by RecallDetector.

Related Recalls

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