The Recall Desk
HighFDA (Devices)·Z-0158-2014·Announced 2013-11-13

Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

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

What this means for you

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 medical device 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 830 units of Portex Spinal Tray with Drugs 25g Whitacre (Lot Number 2440517). 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.

Healthcare providers and consumers should stop using the affected spinal trays and contact Smiths Medical ASD, Inc. for instructions on returning the product.

The recalled product

Product
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-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, lumbar p
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Spinal Anesthesia Trays
Hazard
Affected units
830

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: 2440517

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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