Recall Z-0051-2020— Repro-Med Systems, Inc.

Name: FDA recall Z-0051-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-20

Class II · Terminated

Class II FDA medical device recall by Repro-Med Systems, Inc., initiated 2019-08-20, terminated 2020-05-29. It names one FDA 510(k) clearance: K122404. 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.. Reason: Mislabeled needle lengths.

Recalling firm: Repro-Med Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-20
Terminated: 2020-05-29
Firm location: Chester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K122404 — MODEL 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

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Mislabeled needle lengths

Data sourced from openFDA. This site is unofficial and independent of the FDA.