FDA-Device2019-08-21Class II
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.
Degania Silicone, Ltd.
Hazard
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
Sold states
Nationwide Distribution
Affected count
2700
Manufactured in
Degania Bet, N/A, Dganya Bet, N/A, Israel
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2267-2019Don't want to check this manually?
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