Reported Sep 6, 2017 · Terminated
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)…
Kentec Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kentec Medical Inc · 17871 Fitch · Irvine, CA · 92614-6001
Is this the product you have?
10 of 10 products
| # | Product as published |
|---|---|
| 1 | ENF-50P-40 |
| 2 | ENF-50P-50 |
| 3 | ENF-50P-80 |
| 4 | ENF-60P-40 |
| 5 | ENF-60P-50 |
| 6 | ENF-60P-80 |
| 7 | ENF-80P-40 |
| 8 | ENF-80P-50 |
| 9 | ENF-80P-80 |
| 10 | ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX. |
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 ENF-50P-40, lot number KS1606031 2 ENF-50P-50, lot number KS1606028 3 ENF-50P-80, lot number KS1608007 4 ENF-60P-40, lot number KS1608008 5 ENF-60P-50, lot number KS1606029 6 ENF-60P-80, lot number KS1608009 7 ENF-80P-40, lot number KS1606032 8 ENF-80P-50, lot number KS1606030 9 ENF-80P-80, lot number KS1606034 10 ENF-100P-110, lot number KS1608010 - Amount recalled
- 54 boxes of 10 individual units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Inadequate detectability of radiopaque stripes
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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