The Recall Desk
HighFDA (Devices)·Z-3074-2017·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where the defect (inadequate radiopacity) could lead to misplacement, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Kentec Medical Inc is recalling specific lots of Polyurethane ENFit(R) Ameritus NG Feeding Tubes, with side port, intended for pediatric and neonatal use. The recall involves nine specific reference numbers (ENF-Y50P-40 through ENF-Y80P-90) and associated lot numbers (KS1608011 through KS1606038). The product is sterile, single-use, and packaged in boxes of 10.

The reason for the recall is inadequate detectability of the radiopaque stripes. Radiopaque stripes are used to visualize the position of the tube via imaging; if they are not detectable, it may be difficult to confirm the tube's placement.

The affected products were distributed in Texas, Virginia, Illinois, California, and Kansas. Consumers and healthcare facilities should stop using the affected lots and contact Kentec Medical Inc for further instructions or a return.

The recalled product

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,
Manufacturer
Kentec Medical Inc
Category
Medical Device — Nasogastric Feeding Tubes
Hazard
Affected units
100,526

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 2 recalled by Kentec Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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