Degania Silicone, Ltd.: Medical Device Recall in 2019 - (Recall #: Z-2267-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 28, 2019

Date Posted: August 21, 2019

Recall Number: Z-2267-2019

Event ID: 83287

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

Status: Terminated

Product Quantity: 2700

Code Information:

Lot Code: P1838322, P1858869

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated