Smiths Medical Recalls Portex Regional Anesthesia Trays with Visual Particulates
Smiths Medical is recalling Portex Regional Anesthesia Trays because visual particulates were 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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 100 units of Portex Regional Anesthesia Trays with Drugs (catalog number 15548-20). The recall is due to the presence of visual particulates 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) included in the 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. The specific lot number for the recalled trays is 2450807.
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¿ Regional Anesthesia Tray with Drugs; 15548-20 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 pu
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Anesthesia
- Hazard
- 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 Number: 2450807
Distribution
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.
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