Uri-Drain Combo Kit for Male Incontinenc

• 3 recalls, same reason

  • Terminated Z-2392-2011 FDA Unclassified (pre-2012) ·initiated 29 Apr 2011
  • Terminated Z-2393-2011 FDA Unclassified (pre-2012) ·initiated 29 Apr 2011
  • Terminated Z-2394-2011 FDA Unclassified (pre-2012) ·initiated 29 Apr 2011

  A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination

510(k) Number

K770789 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Kangaroo Enteral Feeding Pump

  Class II

  FDA 510(k) K801725 Active Cleared 13 Aug 1980

• Dispos-A-Care Thermometer Sheath

  Class II

  FDA 510(k) K770125 Active Cleared 14 Mar 1977

• Kangaroo Nasogastric Feeding Tube

  Class II

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• Voldyne Volumetric Incentive Deep Br. Ex

  Class II

  FDA 510(k) K801199 Active Cleared 4 Jun 1980

• Chesebrough-Pond's Reusable Urinary Leg

  Class II

  FDA 510(k) K842553 Active Cleared 20 Jul 1984

• Sterile Absorbent Gauze Burn & Sound

  Unclassified

  FDA 510(k) K840745 Active Cleared 23 Apr 1984

See all devices from Chesebrough-Pond'S U.S.A. Co. →

• What is the URI-Drain Combo Kit for male incontinence used for?

  The URI-Drain Combo Kit is designed to manage urinary incontinence in males by providing continuous urinary drainage. It combines components for drainage and collection, ensuring safe and hygienic urine management for patients requiring indwelling catheter support. This helps prevent leakage and discomfort, making it suitable for clinical settings like hospitals, urology clinics, or home healthcare environments.

• How is the URI-Drain Combo Kit supplied, and is it sterile?

  The URI-Drain Combo Kit is supplied as a single-use, sterile assembly. This ensures that each kit is free from contamination and ready for immediate clinical use without the need for additional sterilization, reducing the risk of infection for the patient.

• Is the URI-Drain Combo Kit intended for single-use or reuse?

  The URI-Drain Combo Kit is explicitly designed for single-use only per manufacturer specifications. This design choice minimizes the risk of cross-contamination and ensures patient safety, as reuse could compromise sterility and integrity of the components.

• What regulatory pathway was followed for the FDA clearance of this device?

  The URI-Drain Combo Kit was granted FDA 510(k) clearance under the Traditional review pathway, classified as a Class II device. It was determined to be substantially equivalent to a predicate device and adheres to FDA regulation 876.5250, which governs urine collectors and accessories for indwelling catheters.

• Can this kit be used with any existing catheter system, or are there specific compatibility requirements?

  The URI-Drain Combo Kit is intended for use with existing catheter systems to provide continuous urinary drainage. While no explicit compatibility restrictions are listed in the provided data, it is always recommended to verify compatibility with the specific catheter system in use to ensure proper function and avoid potential leaks or discomfort for the patient.