Z-1284-2025 Class I Ongoing
FDA device recall Z-1284-2025 was initiated by Smiths Medical ASD, Inc. on February 13, 2025 and is designated Class I. Reason for recall: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. The recall status is ongoing. Affected quantity: 1 unit.
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
- 1 unit
Product Description
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
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 10610586012723, Lot Numbers: 4235509