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Recall Observatory FDA recall evidence

Device product

Medtronic DLP Coronary Ostial Cannulae, Model Number 30050

Z-1795-2024

March 19, 2024

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 94274
Status
Ongoing
Classification
Class II
Quantity
250 units
Official record key
device-enforcement:Z-1795-2024

Official wording

Reason: Potential for unsealed sterile packing.

Code information: GTIN 00613994576019, Lot Numbers: 2023070529; GTIN 20613994576013, Lot Numbers: 2023070529

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for unsealed sterile packing.