Recall Z-0051-2020 ยท FPA Set, Administration, Intravascular
Repro-Med Systems, Inc.
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.
| Date | Aug 20, 2019 |
| Status | Terminated |
| Reason | Mislabeled needle lengths |
| 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 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122404 | MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 Repro-Med Systems, Inc. Dba Rms Medical Products, May 6, 2013 |