Z-2267-2019 Class II Terminated
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
- 2700
Product Description
Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 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 Code: P1838322, P1858869