Medical device recalls Moderate risk

Degania Silicone, Ltd. recalls Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/d…

Recall date
June 28, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2265-2019
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

Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 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.

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