Recall Z-1286-2025— Smiths Medical ASD, Inc.

Name: FDA recall Z-1286-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-13

Class I · Ongoing

Class I FDA medical device recall by Smiths Medical ASD, Inc., initiated 2025-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24. Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-02-13
Firm location: Minneapolis, MN, United States

Product description

smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Data sourced from openFDA. This site is unofficial and independent of the FDA.