Medical device recalls High risk

Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

Recall date
February 13, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1277-2025
FDA classification
Class I
Brand / firm
Smiths Medical ASD, Inc.
Sold / distributed
Worldwide distribution.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

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