Z-1280-2025 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
- 9506 units
Product Description
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
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 10610586012563, Lot Numbers: 3926121, 3928189, 3953709, 3957303, 4006476, 4008521, 4036894, 4046803, 4096337, 4108664, 4114114, 4114115, 4136363, 4146466, 4153872, 4173601, 4232305, 4235508, 4235598, 4271453, 4291483, 4294059, 4317075, 4317092, 4358052, 4366693, 4366694, 4387733, 4434229, 4449244, 4453603, 4453604, 4453605, 6001912, 6026649, 6051324, 6062012, 6071257, 6077416.