Z-0471-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2024
- Initiation Date
- October 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
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 Pattern
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: 4716; UDI-DI: M84947160; Lot Number: H01-24-076.