POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE… recallZ-3074-2017 · Kentec Medical Inc · initiated Jun 23, 2017
Class II Terminated All recalls posted in July 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Kentec Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inadequate detectability of radiopaque stripes
FDA root cause category: Process control
What the company is doing
The firm notified their consignees by telephone and email on 06/23/2017, and followed with a letter sent certified mail, on 07/07/2017. The letter instructed the consignee to cease use of the product, isolate it, and contact Kentec.
Recall details
- Recall number
- Z-3074-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 23, 2017
- Posted by the FDA
- Jul 22, 2017
- Recalling firm
- Kentec Medical Inc
- Quantity
- K100526
- Product code
- FPD
- FDA submissions
- K100526
- Distribution
- TX, VA, IL, CA, KS
Product description
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, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
5 devices cleared under K100526 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Ameritus ENFit ENF-Y80P-40Kentec Medical, Inc. · Tube, Feeding2 reports
- Ameritus AEG-40P-50Kentec Medical, Inc. · Tube, Feeding1 report
- Ameritus AEG-60P-80Kentec Medical, Inc. · Tube, Feeding1 report
- Ameritus ENFit ENF-60P-40Kentec Medical, Inc. · Tube, Feeding1 report
- Ameritus ENFit ENF-80P-40Kentec Medical, Inc. · Tube, Feeding1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 77729).
- Z-3073-2017 · TerminatedPOLYURETHANE 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) EN…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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