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Recall Observatory FDA recall evidence

Device product

STRADIS HEALTHCARE, Breast, Item No.693-276,

Z-0555-2023

November 02, 2022

Class II

Product summary

Firm
Stradis Medical, LLC dba Stradis Healthcare
Event
Event 91124
Status
Ongoing
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-0555-2023

Official wording

Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Code information: UDI/DI (case) M7526932761, UDI/DI (kit)M7526932760, Serial/Lot Numbers: 22242490001

Distribution pattern: US nationwide distribution, and Canada.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    bag being incompletely sealed, which may result in a breach
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    bag being incompletely sealed, which may result in a breach in the sterility