| Class 2 Device Recall RMS HlgHFlo Subcutaneous Safety Needle Set |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FPA
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