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Recall Observatory FDA recall evidence

Device 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, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.

Z-3074-2017

June 23, 2017

Class II

Product summary

Firm
Kentec Medical Inc
Event
Event 77729
Status
Terminated
Classification
Class II
Quantity
K100526
Official record key
device-enforcement:Z-3074-2017

Official wording

Reason: Inadequate detectability of radiopaque stripes

Code information: 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 pattern: TX, VA, IL, CA, KS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inadequate detectability of radiopaque stripes