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Recall Observatory FDA recall evidence

Device product

CADD Administration Sets, Model #21-7346-24

Z-0148-2022

July 14, 2020

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 88730
Status
Terminated
Classification
Class II
Quantity
371 units
Official record key
device-enforcement:Z-0148-2022

Official wording

Reason: Product may have been manufactured with an air filter assembled in an incorrect orientation.

Code information: Lot Numbers: 3750848, 3776357, 3793886, 3766764, 3793887, 3796141, 3776356, 3793888, 3847669

Distribution pattern: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product may have been manufactured with an air filter assembled in an incorrect orientation.