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Recall Observatory FDA recall evidence

Device product

Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

Z-0771-2023

December 02, 2022

Class II

Product summary

Firm
Remington Medical, Inc.
Event
Event 91275
Status
Terminated
Classification
Class II
Quantity
290 devices
Official record key
device-enforcement:Z-0771-2023

Official wording

Reason: The stylet is longer than specified on the label

Code information: UDI/DI 00813079020936, Lot Number 2224920, exp. 2025-09/06

Distribution pattern: NC, WV, CA, PA, AL, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The stylet is longer than specified on the label