Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles
Smiths Medical is recalling 54,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.
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 high-risk medical device (insulin syringe) with a physical defect (particulate) that poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 54,000 units of Hypodermic Needle-Pro Fixed Needle Insulin Syringes (0.5ml 29g x 1/2 in.). The specific lot number is 2358702. These sterile, single-use devices are intended for the injection of U-100 insulin only and are distributed by Cardinal Health.
The recall was initiated because visible orange or brown particulate was found on the needles of the affected syringes. The product was distributed nationwide in the United States, including in Arizona, California, Florida, Illinois, Louisiana, Missouri, Mississippi, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin, and West Virginia. The syringes were also distributed in Canada, Italy, and Spain.
Consumers should stop using the affected syringes and contact Smiths Medical or their healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single us
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Syringes
- Affected units
- 54,000
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 Numbers: 2358702
Distribution
Part of a larger recall action
This product is one of 5 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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