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Terminated

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.

FDA Recall Z-0051-2020 · Posted None

Recalling FirmRepro-Med Systems, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2019-08-20
Date Terminated2020-05-29
Product Quantity1990 pouches

Reason for Recall

Mislabeled needle lengths

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution including the states of NJ, OH, FL, GA, IL, MA, CA, TX, NC, IA, NV, OR, MD, TN, VA, NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122404MODEL 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 · 2013-05-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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