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
Product summary
- 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
Potential for unsealed sterile packing.