FDAFDA · Food and drugs·Recall number Z-2265-2019
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.
Published August 21, 2019 · Recall initiated: June 28, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Degania Silicone, Ltd.
- Distributor
- Nationwide Distribution
- Lot
- Lot Codes: P1851056 P1867059
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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