Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0161-2014·Announced 2013-11-13

Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

Smiths Medical is recalling Portex Spinal Trays because visual particulate was found in the lidocaine and dextrose 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 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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 1,904 units of Portex Spinal Trays with Drugs 25g Whitacre (model 15597C-20). 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 ampules are included in the affected spinal trays.

The affected products were distributed nationwide to the following states: AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, and WY. The specific lot numbers for the recalled trays are 2426443, 2431124, 2440524, and 2450808.

Healthcare providers and consumers should stop using the affected spinal trays and contact Smiths Medical ASD, Inc. for instructions on how to return the product for a refund or replacement.

The recalled product

Product: Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-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…
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Spinal Anesthesia Trays
Hazard: contamination
particulate
Affected units: 1,904

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 (4)

Lot: 2426443
2431124
2440524
2450808

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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