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Recall Observatory FDA recall evidence

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

Z-3073-2017

June 23, 2017

Class II

Product summary

Firm
Kentec Medical Inc
Event
Event 77729
Status
Terminated
Classification
Class II
Quantity
54 boxes of 10 individual units
Official record key
device-enforcement:Z-3073-2017

Official wording

Reason: Inadequate detectability of radiopaque stripes

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inadequate detectability of radiopaque stripes