FDA recall Z-0475-2025

Hobbs Medical, Inc. · Class II · device

Product

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722

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.

Key facts

Status
Ongoing
Initiation date
2024-10-04
Report date
2024-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stafford Springs, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0475-2025