FDA recall Z-0051-2020

Repro-Med Systems, Inc. · Class II · device

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 for recall

Mislabeled needle lengths

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-08-20
Report date
2019-10-16
Termination date
2020-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0051-2020