Home / Recalls / Repro-Med Systems, Inc. / Z-0051-2020

Z-0051-2020 Class II Terminated

Recalled by Repro-Med Systems, Inc. — Chester, NY

FDA device recall Z-0051-2020 was initiated by Repro-Med Systems, Inc. on August 20, 2019 and is designated Class II. Reason for recall: Mislabeled needle lengths The recall status is terminated (terminated May 29, 2020). Affected quantity: 1990 pouches.

Recall Details

Product Type: Devices
Report Date: October 16, 2019
Initiation Date: August 20, 2019
Termination Date: May 29, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1990 pouches

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

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.

Code Information

Lot # N.78648 GTIN: 00659443000292