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Recall Observatory FDA recall evidence

Device product

Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000

Z-1802-2024

March 19, 2024

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 94274
Status
Ongoing
Classification
Class II
Quantity
1624 units
Official record key
device-enforcement:Z-1802-2024

Official wording

Reason: Potential for unsealed sterile packing.

Code information: a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 20643169880959, Lot Numbers: 2023030431, 2023030432, 2023030433, 2023030734, 202305C226, 202307C176, 202307C177; b) Model Number 62000, GTIN 20613994846642, Lot Numbers: 2023030223, 2023030736, 2023031580, 202305C225

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for unsealed sterile packing.