The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0160-2014·Announced 2013-11-13

Smiths Medical Recalls Portex Spinal Trays with Visual Particulate in Ampules

Smiths Medical ASD, Inc. is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving medical devices with potential for serious injury or hospitalization are categorized as Severe (Score 4).

Plain-English summary

Smiths Medical ASD, Inc. is recalling 3,980 units of Portex Spinal Anaesthesia Trays. The recall involves specific lots (2445604, 2440523, 2445605, 2445606, 2450812) of the Portex Spinal Tray with Drugs 25g Whitacre (catalog number 15597-20). These sterile, single-use devices are designed for regional anesthesia procedures, including spinal and epidural anesthesia.

The recall was initiated 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 FDA has classified this as a Class II recall.

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 facilities should stop using the affected trays and contact Smiths Medical ASD, Inc. for further instructions.

The recalled product

Product
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 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 — Regional Anesthesia
Hazard
Affected units
3,980

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 (5)

  • Lot: 2445604
  • 2440523
  • 2445605
  • 2445606
  • 2450812

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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