Z-0051-2020Class II

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

Name: Z-0051-2020 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 -
Creator: Repro-Med Systems, Inc.
Published: 2019-08-20
License: https://open.fda.gov/license/

Repro-Med Systems, Inc. / initiated 2019-08-20 / Terminated / root cause: labeling and UDI

FDA source

Repro-Med Systems, Inc. began a recall of 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are... on 2019-08-20. FDA classified it as Class II and gives the reason as "Mislabeled needle lengths". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0051-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-20
Posted: 2019-10-07
Terminated: 2020-05-29
Recalling firm: Repro-Med Systems, Inc.
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Mislabeled needle lengths
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Lot # N.78648 GTIN: 00659443000292

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0051-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0051-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07

Product code FPA

K122404Class IIModel Number: Rms1-2604, Rms1-2614, Rms1-2404, Rms1-2414, Rms2-2604, Rms2-2614, Rms2-2404, Rms2-2414, Rms3-2604, Rms3-26Repro-Med Systems, Inc. Dba Rms Medical Products / cleared 2013-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)