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U.S. Department of Health and Human Services

Class 2 Device Recall ENFit(R) AMERITUS NG FEEDING TUBE

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  Class 2 Device Recall ENFit(R) AMERITUS NG FEEDING TUBE see related information
Date Initiated by Firm June 23, 2017
Date Posted July 22, 2017
Recall Status1 Terminated 3 on April 14, 2020
Recall Number Z-3074-2017
Recall Event ID 77729
510(K)Number K100526  
Product Classification Tube, feeding - Product Code FPD
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.
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 
Recalling Firm/
Manufacturer		 Kentec Medical Inc
17871 Fitch
Irvine CA 92614-6001
For Additional Information Contact Keith Rooks
949-863-0810 Ext. 118
Manufacturer Reason
for Recall		 Inadequate detectability of radiopaque stripes
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce K100526
Distribution TX, VA, IL, CA, KS
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPD and Original Applicant = KENTEC MEDICAL, INC.
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