Reported Sep 6, 2017 · Terminated
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c)…
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?
9 of 9 products
| # | Product as published |
|---|---|
| 1 | ENF-Y50P-40 |
| 2 | ENF-Y50P-50 |
| 3 | ENF-Y60P-40 |
| 4 | ENF-Y60P-50 |
| 5 | ENF-Y60P-90 |
| 6 | ENF-Y80P-40 |
| 7 | ENF-Y80P-50 |
| 8 | ENF-Y80P-80 |
| 9 | ENF-Y80P-90 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX. |
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 ENF-Y50P-40, lot number KS1608011 2 ENF-Y50P-50, lot number KS1608012 3 ENF-Y60P-40, lot number KS1608013 4 ENF-Y60P-50, lot number KS1608014 5 ENF-Y60P-90, lot number KS1608015 6 ENF-Y80P-40, lot number KS1606035 7 ENF-Y80P-50, lot number KS1606036 8 ENF-Y80P-80, lot number KS1606037 9 ENF-Y80P-90, lot number KS1606038 - Amount recalled
- K100526
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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