Z-1283-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1961 units
Product Description
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Reason for Recall
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 10610586012716, Lot Numbers: 3941279, 3969275, 3984421, 4022601, 4136364, 4148590, 4153873, 4196768, 4227788, 4232310, 4235600, 4248718, 4276227, 4302980, 4307478, 4317093, 4325880, 4358053, 4358054, 4395512, 4415445, 4420760, 4437255, 4449234, 4449877, 4460620, 6013083, 6003891, 6053532, 6062026.