Medical device recalls Moderate risk

Repro-Med Systems product recalled over labeling errors

Recall date
August 20, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Repro-Med Systems, Inc. recalls 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Su…
Recall number
Z-0051-2020
FDA classification
Class II
Brand / firm
Repro-Med Systems, Inc.
Sold / distributed
US Nationwide distribution including the states of NJ, OH, FL, GA, IL, MA, CA, TX, NC, IA, NV, OR, MD, TN, VA, NY.

Why it was recalled

Mislabeled needle lengths

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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