Smiths Medical ASD Inc. recalls PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

Recall date

June 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2499-2020

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

Domestic Distribution: AR, CT, MS,TN,TX

Why it was recalled

Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.