HIgH-Flo Needle Set recallZ-0051-2020 · Repro-Med Systems, Inc. · initiated Aug 20, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Repro-Med Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mislabeled needle lengths
FDA root cause category: Under Investigation by firm
What the company is doing
1. If you have possession of any pouches from Lot N.78648 should return them to RMS Medical Products immediately . 2. Please complete and return the enclosed response form as soon as possible. If you have any questions, call RMS Medical Products (845) 469-2042 Customers who have questions should contact RMS by email at [email protected] or by phone at 1-800-624-9600 or (845) 469-2042, Monday through Friday, 8:00 AM - 4:30 PM., Eastern Time. Customers may also reach out to their RMS sales representative.
Recall details
- Recall number
- Z-0051-2020
- Status
- Terminated
- Initiated by the company
- Aug 20, 2019
- Recalling firm
- Repro-Med Systems, Inc.
- Quantity
- 1990 pouches
- Product code
- FPA
- FDA submissions
- K122404
- Distribution
- US Nationwide distribution including the states of NJ, OH, FL, GA, IL, MA, CA, TX, NC, IA, NV, OR, MD, TN, VA, NY.
Product description
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.
Code information (models, lots, serial numbers)
Lot # N.78648 GTIN: 00659443000292
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HIgH-Flo™ Needle Set RMS22606Repro Med Systems, Inc. · Set, administration, intravascular1 recall0 reports
Product lines
Other devices under the same FDA submission
10 devices cleared under K122404 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HIgH-Flo™ Needle Set RMS22609Repro Med Systems, Inc. · Set, administration, intravascular2 reports
- HIgH-Flo™ Needle Set RMS52609Repro Med Systems, Inc. · Set, administration, intravascular2 reports
- HIgH-Flo™ Needle Set RMS12414Repro Med Systems, Inc. · Set, administration, intravascular2 reports
- HIgH-Flo™ Needle Set RMS32409Repro Med Systems, Inc. · Set, administration, intravascular2 reports
- HIgH-Flo™ Needle Set RMS32614Repro Med Systems, Inc. · Set, administration, intravascular1 report
- HIgH-Flo™ Needle Set RMS12409Repro Med Systems, Inc. · Set, administration, intravascular1 report
- HIgH-Flo™ Needle Set RMS22409Repro Med Systems, Inc. · Set, administration, intravascular1 report
- HIgH-Flo™ Needle Set RMS22414Repro Med Systems, Inc. · Set, administration, intravascular1 report
- HIgH-Flo™ Needle Set RMS32414Repro Med Systems, Inc. · Set, administration, intravascular1 report
- HIgH-Flo™ Needle Set RMS42412Repro Med Systems, Inc. · Set, administration, intravascular1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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