The Recall Desk
HighFDA (Devices)·Z-3073-2017·Announced 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.

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 involves a medical device defect (inadequate radiopaque stripe detectability) that poses a risk of harm by potentially compromising the ability to verify tube placement, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Kentec Medical Inc is recalling 54 boxes of polyurethane ENFit Ameritus nasogastric feeding tubes intended for pediatric and neonatal use. The recall involves ten specific reference numbers and lot numbers, including ENF-50P-40, ENF-50P-50, and ENF-100P-110. The affected products are sterile, single-use tubes packaged in boxes of 10.

The recall was initiated because the radiopaque stripes on the tubes are inadequately detectable. Radiopaque stripes are critical for medical professionals to visualize the position of the tube via imaging. If the stripes are not detectable, it may be difficult to confirm the correct placement of the feeding tube in the patient.

The affected units were distributed to facilities in Texas, Virginia, Illinois, California, and Kansas. Healthcare providers and facilities should stop using the affected lots immediately and contact Kentec Medical Inc for instructions on return or replacement. Consumers should not use these products and should contact their healthcare provider if they have questions regarding the recall.

The recalled product

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, RADIOPAQ
Manufacturer
Kentec Medical Inc
Category
Medical Device — Feeding Tubes
Hazard

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 (11)

  • 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

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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