Device Recall ENFit(R) AMERITUS NG FEEDING TUBE

  • Model / Serial
    a) ENF-Y50P-40, lot number KS1608011 b) ENF-Y50P-50, lot number KS1608012 c) ENF-Y60P-40, lot number KS1608013 d) ENF-Y60P-50, lot number KS1608014 e) ENF-Y60P-90, lot number KS1608015 f) ENF-Y80P-40, lot number KS1606035 g) ENF-Y80P-50, lot number KS1606036 h) ENF-Y80P-80, lot number KS1606037 i) ENF-Y80P-90, lot number KS1606038
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    TX, VA, IL, CA, KS
  • Product Description
    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: || a) ENF-Y50P-40 || b) ENF-Y50P-50 || c) ENF-Y60P-40 || d) ENF-Y60P-50 || e) ENF-Y60P-90 || f) ENF-Y80P-40 || g) ENF-Y80P-50 || h) ENF-Y80P-80 || i) ENF-Y80P-90 || For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Kentec Medical Inc, 17871 Fitch, Irvine CA 92614-6001
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    a) ENF-50P-40, lot number KS1606031 b) ENF-50P-50, lot number KS1606028 c) ENF-50P-80, lot number KS1608007 d) ENF-60P-40, lot number KS1608008 e) ENF-60P-50, lot number KS1606029 f) ENF-60P-80, lot number KS1608009 g) ENF-80P-40, lot number KS1606032 h) ENF-80P-50, lot number KS1606030 i) ENF-80P-80, lot number KS1606034 j) ENF-100P-110, lot number KS1608010
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    TX, VA, IL, CA, KS
  • Product Description
    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: || a) ENF-50P-40 || b) ENF-50P-50 || c) ENF-50P-80 || d) ENF-60P-40 || e) ENF-60P-50 || f) ENF-60P-80 || g) ENF-80P-40 || h) ENF-80P-50 || i) ENF-80P-80 || j) ENF-100P-110 || For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
  • Manufacturer