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Recall Observatory FDA recall evidence

Device product

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706

Z-0470-2025

October 04, 2024

Class II

Product summary

Firm
Hobbs Medical, Inc.
Event
Event 95577
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0470-2025

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: 4706; UDI-DI: M84947060; Lot Number: SD09-23-089.

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

    reason.no_named_rule · v1.0.0

    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.