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Recall Observatory FDA recall evidence

Device product

Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001

Z-1796-2024

March 19, 2024

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 94274
Status
Ongoing
Classification
Class II
Quantity
7935 units
Official record key
device-enforcement:Z-1796-2024

Official wording

Reason: Potential for unsealed sterile packing.

Code information: GTIN 00613994575319, Lot Numbers: 2023041320, 2023041323; GTIN 00673978180465, Lot Numbers: 2023041316, 2023041323; GTIN 20613994575313, Lot Numbers: 2023041316, 2023041318, 2023041320, 2023041323, 202305C146, 202305C154

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for unsealed sterile packing.