Z-1798-2024 Class II Ongoing
FDA device recall Z-1798-2024 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: 1760 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Mar 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1760 units
Product Description
Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
Reason for Recall
Potential for unsealed sterile packing.
Distribution Pattern
Worldwide distribution.
Code Information
a) Model Number 79004, GTIN 20613994576389, Lot Numbers: 2023081324; b) Model Number 79009, GTIN 20613994576457, Lot Numbers: 2023041000, 2023041384, 202305C235
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1798-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026