FDA Enforcement
Class II
Ongoing
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Recall: Z-0468-2025
·
Reported November 27, 2024
Enforcement
- Recall Number
- Z-0468-2025
- Event ID
- 95577
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Hobbs Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2024
- Initiation Date
- October 4, 2024
- Classification Date
- November 15, 2024
- Address
- 8 Spring St, N/A, Stafford Springs, CT, 06076-1505, United States
Description
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
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 Info
Catalog Number: 4720; UDI-DI: M84947200; Lot Numbers: H07-23-103, H07-23-104, H08-23-020, H09-23-111.
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
70 units