The Recall Desk
ModerateFDA (Devices)·Z-0156-2014·Announced 2013-11-13

Smiths Medical Recalls Portex Spinal Trays Due to Visual Particulate

Smiths Medical ASD, Inc. is recalling 140 Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

What this means for you

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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is limited to visual particulate in the ampules, fitting the criteria for a moderate severity score.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 140 units of Portex Spinal Trays with Drugs (22g Whitacre/25g Whitacre; 15248C-22/25). 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 affected spinal trays.

The affected product is identified by Lot Number 2440516. The recall covers a nationwide distribution across 38 states and the District of Columbia, including 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.

Healthcare providers and facilities should stop using the affected spinal trays and contact Smiths Medical ASD, Inc. for instructions on returning the product. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 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, nerv
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Spinal Anesthesia
Hazard
Affected units
140

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: 2440516

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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