Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0162-2014·Announced 2013-11-13

Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

Smiths Medical is recalling Portex Spinal Anaesthesia Trays because some included glass ampules contain visual particulate matter.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves visual particulate matter in injection ampules. No specific injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 100 units of Portex Saddleblock Tray with Drugs 26g Quincke, catalog number 4745-20, lot 2445619. The recall is due to the presence of visual particulate matter 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 trays and contact Smiths Medical ASD, Inc. for further instructions or a replacement.

The recalled product

Product: Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 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…
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Spinal Anesthesia Trays
Hazard: particulate-contamination
Affected units: 100

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: 2445619

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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