The Recall Desk

FDA (Devices) recall action 77729

Kentec Medical Inc recalled 2 products on 2017-09-06

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-09-06
Critical
0
Units
100,526

Why these products were recalled

Inadequate detectability of radiopaque stripes

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2017-09-06

    Kentec Medical Recalls Pediatric Nasogastric Feeding Tubes Due to Radiopaque Stripe Defect

    Kentec Medical Inc is recalling specific lots of polyurethane ENFit nasogastric feeding tubes for pediatric and neonatal use because the radiopaque stripes are inadequately detectable.

    Product
    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…
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2017-09-06

    Kentec Medical Recalls Pediatric Nasogastric Feeding Tubes Due to Radiopaque Stripe Issue

    Kentec Medical Inc is recalling specific lots of Polyurethane ENFit Ameritus NG Feeding Tubes because the radiopaque stripes may be inadequately detectable.

    Product
    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…
    Category
    Distribution
    5 states