Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
FDA Recall #Z-0474-2025 — Class II — October 4, 2024
Product Description
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Reason for Recall
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Recalling Firm
Hobbs Medical, Inc. — Stafford Springs, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12 units
Distribution
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
Code Information
Catalog Number: 4718; UDI-DI: M84947180; Lot Numbers: H08-23-264, H09-23-112.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated