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Recall Observatory FDA recall evidence

Device product

Medtronic Clearview Blower/Mister, Model Number 22120

Z-1794-2024

March 19, 2024

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 94274
Status
Ongoing
Classification
Class II
Quantity
500 units
Official record key
device-enforcement:Z-1794-2024

Official wording

Reason: Potential for unsealed sterile packing.

Code information: GTIN 20643169888672, Lot Numbers: 2023040203, 2023040473

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for unsealed sterile packing.