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Hobbs Medical, Inc. Recall 95577

Description: Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723

Hobbs Medical, Inc. Recall 95577 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0476-2025
Event ID95577
Event DescriptionPosi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Product TypeDevices
DistributionWorldwide - 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.
Quantity10 units
Recall ReasonInjection 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 Classification20241127
Device Code InfoCatalog Number: 4723; UDI-DI: M84947230; Lot Numbers: H07-23-107, H08-23-034.
Center Classification Date20241115
Recall Initiation Date20241004
Recalling FirmHobbs Medical, Inc.
Initial Notification Letter
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