Z-1428-2025 Class II Ongoing
FDA device recall Z-1428-2025 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: 4400 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
- 4400 units
Product Description
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
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 10193489067507 (each), 20193489067504 (case), Lot number 0000140528