Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination
Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the included 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 3/5 (High).
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 in injection ampules) 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 222 units of Portex Saddleblock Tray with Drugs – 25g Quincke (catalog number 4795-20). 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 specific ampules are included in the recalled spinal anesthesia 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 2455104.
Healthcare providers and consumers should stop using these products immediately. The Portex Saddleblock Tray is a sterile, single-use device designed for regional anesthesia procedures, including epidural, spinal, and nerve block procedures. Users should contact Smiths Medical ASD, Inc. for further instructions on returning or disposing of the affected units.
The recalled product
- Product
- Portex¿ Saddleblock Tray with Drugs 25g Quincke; 4795-20 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…
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Anesthesia
- Hazard
- Affected units
- 222
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: 2455104
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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