Degania Silicone, Ltd. recalls Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is…

Recall date

June 28, 2019

Source

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

Recall number

Z-2267-2019

FDA classification

Class II

Brand / firm

Degania Silicone, Ltd.

Sold / distributed

Nationwide Distribution

Why it was recalled

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

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

What was recalled

Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.