Agency classClass IIOur severity:High FDA (Devices)·Z-0157-2014·Announced 2013-11-13

Portex Spinal Trays Recalled Due to Visual Particulate in Lidocaine Ampules

Smiths Medical ASD is recalling 73 Portex Spinal Trays because visual particulate was found in the included Lidocaine HCL ampules.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (injection) with a contamination hazard (visual particulate) where no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 73 units of Portex Spinal Tray with Drugs 22g/25g Quincke (Lot Number 2445601). The recall is due to the presence of 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 specific ampules are included in the recalled spinal trays.

The affected products were distributed nationwide, including in Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and Wyoming.

Healthcare providers and consumers should stop using the affected spinal trays immediately and contact Smiths Medical ASD, Inc. for further instructions or a return.

The recalled product

Product: Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 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…
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Spinal Anesthesia Trays
Hazard: contamination
visual-particulate
Affected units: 73

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot Number: 2445601

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 9 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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