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.
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. 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. Quantity: 6 units Lot/code info: Catalog Number: 4704; UDI-DI: M84947040; Lot Numbers: H10-23-106, H11-23-059.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.