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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) 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.

FDA Recall Z-3073-2017 · Posted 2017-07-22

Recalling FirmKentec Medical Inc
Recall StatusTerminated
Product CodeFPD
Date Initiated2017-06-23
Date Terminated2020-04-14
Product Quantity54 boxes of 10 individual units

Reason for Recall

Inadequate detectability of radiopaque stripes

Firm Action

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.

Root Cause

Process control

Distribution Pattern

TX, VA, IL, CA, KS

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100526AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBEKentec Medical, Inc. · 2010-04-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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