Z-2264-2019 Class II Terminated

Recalled by Degania Silicone, Ltd. — Dganya Bet, N/A

Recall Details

Product Type
Devices
Report Date
August 21, 2019
Initiation Date
June 28, 2019
Termination Date
October 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6960

Product Description

Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 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 Pattern

Nationwide Distribution

Code Information

Lot Codes: P1861538 P1865416 P1903570