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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-3073-2017
Recall Event ID 77729
510(K)NumberK100526 
Product Classification Tube, feeding - Product Code FPD
ProductPOLYURETHANE 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.
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 
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 Commerce54 boxes of 10 individual units
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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