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Recall Observatory FDA recall evidence

Device product

Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.

Z-1515-2021

March 31, 2021

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 87642
Status
Terminated
Classification
Class II
Quantity
682 units
Official record key
device-enforcement:Z-1515-2021

Official wording

Reason: The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

Code information: Device Model Number: 55-4090; Lot Number: 3768545

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of PA and MN. The countries of Columbia, Germany, Greece, Hong Kong, Qatar, Thailand, and United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.