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Recall Observatory FDA recall evidence

Device product

EasyPoint Needle, 25G x 5/8", REF: 82091

Z-1293-2024

February 05, 2024

Class II

Product summary

Firm
Retractable Technologies, Inc.
Event
Event 93981
Status
Ongoing
Classification
Class II
Quantity
477,600
Official record key
device-enforcement:Z-1293-2024

Official wording

Reason: The needle cannula of a retractable needle may detach from the needle holder in the patient.

Code information: UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027

Distribution pattern: US Nationwide distribution including in the states of NY, FL, IL, MA, UT, NJ, AZ, MO, WA, NC, CA, TX, NV, IN, PA, VA, IA, GA, TN, MI, OH, OK, CO, OR, SC, MN, CT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The needle cannula of a retractable needle may detach from the needle holder in the patient.