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Recall Observatory FDA recall evidence

Device product

Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175

Z-1625-2016

April 04, 2016

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 73835
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-1625-2016

Official wording

Reason: Device packaging may not be sealed.

Code information: Lot #481938U

Distribution pattern: US distribution to KY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device packaging may not be sealed.