Device product
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Z-0473-2025
Product summary
- Event
- Event 95577
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-0473-2025
Official wording
Reason: 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.
Code information: Catalog Number: 4704; UDI-DI: M84947040; Lot Numbers: H10-23-106, H11-23-059.
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.
Derived failure modes
-
Unknown
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.