FDA Recall 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.

Recall: Z-0051-2020 · Initiated August 20, 2019

Recall

Recall Number
Z-0051-2020
Event Number
83650
Firm
Repro-Med Systems, Inc.
FEI Number
1318360
Product Code
FPA
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
August 20, 2019
Terminated
May 29, 2020
Address
24 Carpenter Rd, Chester, NY, 10918-1057

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

Mislabeled needle lengths

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.

Distribution

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

Quantity

1990 pouches