FDA recall Z-2263-2019

Degania Silicone, Ltd. · Class II · device

Product

Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 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

Distribution

Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2019-06-28
Report date
2019-08-21
Termination date
2020-10-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dganya Bet, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2263-2019