Recall Z-2260-2019— Degania Silicone, Ltd.
Class II · Terminated
Class II FDA medical device recall by Degania Silicone, Ltd., initiated 2019-06-28, terminated 2020-10-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 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.. Reason: 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.
- Recalling firm
- Degania Silicone, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-28
- Terminated
- 2020-10-22
- Firm location
- Dganya Bet, N/A, Israel
Product description
Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.