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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 TUBEsee related information
Date Initiated by FirmJune 23, 2017
Date PostedJuly 22, 2017
Recall Status1 Terminated 3 on April 14, 2020
Recall NumberZ-3074-2017
Recall Event ID 77729
510(K)NumberK100526 
Product Classification Tube, feeding - Product Code FPD
ProductPOLYURETHANE 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 
FEI Number 2080225
Recalling Firm/
Manufacturer		 Kentec Medical Inc
17871 Fitch
Irvine CA 92614-6001
For Additional Information ContactKeith Rooks
949-863-0810 Ext. 118
Manufacturer Reason
for Recall		Inadequate detectability of radiopaque stripes
FDA Determined
Cause 2		Process control
ActionThe 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 CommerceK100526
DistributionTX, VA, IL, CA, KS
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPD
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