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Recall Observatory FDA recall evidence

Device product

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

Z-2401-2021

August 04, 2021

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 88425
Status
Terminated
Classification
Class II
Quantity
1,590 units
Official record key
device-enforcement:Z-2401-2021

Official wording

Reason: The incorrect device is contained in the package.

Code information: Lot 4015424

Distribution pattern: International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The incorrect device is contained in the package.