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U.S. Department of Health and Human Services

Class 2 Device Recall RMS HlgHFlo Subcutaneous Safety Needle Set

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  Class 2 Device Recall RMS HlgHFlo Subcutaneous Safety Needle Set see related information
Date Initiated by Firm August 20, 2019
Create Date October 07, 2019
Recall Status1 Terminated 3 on May 29, 2020
Recall Number Z-0051-2020
Recall Event ID 83650
510(K)Number K122404  
Product Classification Set, administration, intravascular - Product Code FPA
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.
Code Information Lot # N.78648 GTIN: 00659443000292
Recalling Firm/
Manufacturer		 Repro-Med Systems, Inc.
24 Carpenter Rd
Chester NY 10918-1057
For Additional Information Contact RMS
845-469-2042
Manufacturer Reason
for Recall		 Mislabeled needle lengths
FDA Determined
Cause 2		 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 Quality@rmsmedpro.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
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