Hobbs Medical, Inc. Recall 95577
Description: Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Hobbs Medical, Inc. Recall 95577 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0476-2025 |
Event ID | 95577 |
Event Description | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723 |
Product Type | Devices |
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 | 10 units |
Recall 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. |
Device Classification | 20241127 |
Device Code Info | Catalog Number: 4723; UDI-DI: M84947230; Lot Numbers: H07-23-107, H08-23-034. |
Center Classification Date | 20241115 |
Recall Initiation Date | 20241004 |
Recalling Firm | Hobbs Medical, Inc. |
Initial Notification | Letter |
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