Repro-Med Systems Recalls Mislabeled Subcutaneous Safety Needle Sets
Repro-Med Systems is recalling 1,990 pouches of 26-gauge subcutaneous safety needle sets due to mislabeled needle lengths.
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 2/5 (Moderate).
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 involves a labeling error (mislabeled needle lengths) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Repro-Med Systems, Inc. is recalling 1,990 pouches of 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets (Product # RMS22606). The recall is due to mislabeled needle lengths. The affected product is identified by Lot # N.78648 and GTIN 00659443000292.
The product was distributed nationwide in the United States, including New Jersey, Ohio, Florida, Georgia, Illinois, Massachusetts, California, Texas, North Carolina, Iowa, Nevada, Oregon, Maryland, Tennessee, Virginia, and New York. These needle sets are intended for the delivery of medication to the subcutaneous tissue.
Consumers should stop using the affected needle sets and contact Repro-Med Systems, Inc. for further instructions or a return.
The recalled product
- Product
- 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
- Manufacturer
- Repro-Med Systems, Inc.
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 1,990
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 # N.78648 GTIN: 00659443000292
Distribution
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