Z-1802-2024 Class II Ongoing
FDA device recall Z-1802-2024 was initiated by Medtronic Perfusion Systems on Mar 19, 2024 and is designated Class II. Reason for recall: Potential for unsealed sterile packing. The recall status is ongoing. Affected quantity: 1624 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Mar 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1624 units
Product Description
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
Reason for Recall
Potential for unsealed sterile packing.
Distribution Pattern
Worldwide distribution.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1802-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026