Degania Silicone, Ltd.: 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

Agency Publication Date: August 12, 2019

Affected Products

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.

Lot Codes: 1900956, P1900955

Lot Numbers:

Codes

Product: Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 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.

Lot Codes: P1849762, P1836201, P1864643

Lot Numbers:

Codes

Product: Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 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.

Lot Codes: P1841752 P1852268 P1845823

Lot Numbers:

Codes

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.

Lot Code: P1849695, P1858286, P1867022

Lot Numbers:

Code

Product: 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.

Lot Codes: P1861538 P1865416 P1903570

Lot Numbers:

Codes

Product: Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 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.

Lot Codes: P1851056 P1867059

Lot Numbers:

Codes

Product: Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB 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.

Lot Code: P1841839

Lot Numbers:

Code

Product: 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.

Lot Code: P1838322, P1858869

Lot Numbers:

Code

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83287

Status: Resolved

Manufacturer: Degania Silicone, Ltd.

Manufactured In: Israel

Units Affected: 8 products (640 units; 3040; 6080; 4080; 6960; 2160; 200; 2700)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Codes: 1900956, P1900955

Lot Numbers:

Codes

Lot Codes: P1849762, P1836201, P1864643

Lot Numbers:

Codes

Lot Codes: P1841752 P1852268 P1845823

Lot Numbers:

Codes

Lot Code: P1849695, P1858286, P1867022

Lot Numbers:

Code

Lot Codes: P1861538 P1865416 P1903570

Lot Numbers:

Codes

Lot Codes: P1851056 P1867059

Lot Numbers:

Codes

Lot Code: P1841839

Lot Numbers:

Code

Lot Code: P1838322, P1858869

Lot Numbers:

Code