FDAClass IIOctober 16, 2019

20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety recall: Labeling Error

20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets…

Why was 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety recalled?

Mislabeled needle lengths

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # N.78648 GTIN: 00659443000292

Product
20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets…
Recalling firm
Repro-Med Systems, Inc.
Quantity
1990 pouches
Distribution
US Nationwide distribution including the states of NJ, OH, FL, GA, IL, MA, CA, TX, NC, IA, NV, OR, MD, TN, VA, NY.
Recall date
October 16, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls