Nasogastric Feeding Tube Kits

• • Terminated Z-1922-2013 FDA Class II ·initiated 24 Jul 2013

  Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.

510(k) Number

K915439 ↗

FDA Product Code

FPD

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

• Sandoz Nutrition Compat Enteral Feed Pump W/Hydration

  Class II

  FDA 510(k) K940555 Active Cleared 1 Feb 1995

• External Gastrostomy Tube Retainer

  Class II

  FDA 510(k) K912575 Active Cleared 21 Nov 1991

• Gastrointestinal Tube and Accessories

  Class II

  FDA 510(k) K914492 Active Cleared 25 Feb 1992

• Vinyl Bag W/Pump Administration Set

  Class II

  FDA 510(k) K893540 Active Cleared 17 Oct 1989

• Compat (R) Enteral Delivery System

  Class II

  FDA 510(k) K882218 Active Cleared 13 Sep 1988

• Peg Prep Tray

  Class II

  FDA 510(k) K920493 Active Cleared 4 Jan 1993

See all devices from Sandoz Nutrition →