Z-1288-2025 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
- 2236 units
Product Description
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
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 10610586012839, Lot Numbers: 3906623, 3922514, 4120026, 4152690, 4157409, 4196736, 4227806, 4264408, 4271442, 4317086, 4337691, 4382350, 4387734, 4405011, 4440712, 4445592, 4460621, 4468591, 6013085, 6026683, 6037136, 6051319, 6071259.