smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Reported: March 26, 2025 Initiated: February 13, 2025 #Z-1282-2025
Product Description
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Reason for Recall
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Details
- Recalling Firm
- Smiths Medical ASD, Inc.
- Units Affected
- 1695 units
- Distribution
- Worldwide distribution.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24. Recalled by Smiths Medical ASD, Inc.. Units affected: 1695 units.
Why was this product recalled? ▼
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Critical. Recall number: Z-1282-2025.
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