Z-1429-2025 Class II Ongoing
FDA device recall Z-1429-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on February 12, 2025 and is designated Class II. Reason for recall: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. The recall status is ongoing. Affected quantity: 40 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2025
- Initiation Date
- February 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
Product Description
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Reason for Recall
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
Code Information
UDI/DI 10193489064803 (each), 20193489064800 (case), Lot number 0000140054