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Recall Observatory FDA recall evidence

Device product

Trumpet, Needle Guide, Cat# TMS-200

Z-1460-2024

January 31, 2024

Class II

Product summary

Firm
Technicality Inc.
Event
Event 94135
Status
Ongoing
Classification
Class II
Quantity
20000 units
Official record key
device-enforcement:Z-1460-2024

Official wording

Reason: The Ring on the Trump Needle Guide can detach when excessive pressure is applied.

Code information: Lot Numbers: 22190 & 22497

Distribution pattern: US Nationwide distribution in the state of Illinois.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Ring on the Trump Needle Guide can detach when excessive pressure is applied.