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U.S. Department of Health and Human Services

Class 2 Device Recall Ameritus Entral Polyurethane Feeding TubeAmeritus Entral Silicone Feeding Tube

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 Class 2 Device Recall Ameritus Entral Polyurethane Feeding TubeAmeritus Entral Silicone Feeding Tubesee related information
Date Initiated by FirmJanuary 17, 2020
Create DateJuly 08, 2020
Recall Status1 Terminated 3 on October 21, 2022
Recall NumberZ-2520-2020
Recall Event ID 85430
510(K)NumberK100526 
Product Classification Tube, feeding - Product Code FPD
ProductAmeritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
Code Information Lot Number: KS1803011
FEI Number 2080225
Recalling Firm/
Manufacturer		 Kentec Medical, Inc
17871 Fitch
Irvine CA 92614-6001
For Additional Information Contact
949-863-0810
Manufacturer Reason
for Recall		Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 01/02/2020, the firm notified affected customers via mail of "'URGENT' VOLUNTARY RECALL NOTICE". The letter indicated to IMMEDIATELY stop use of affected product and to move affected product to a location that prevents potential use. Contact the firm immediately, via the phone number (800-825-5996) or email to arrange return of the affected product. Complete and sign the attached Voluntary Recall Response Form, to acknowledge the receipt and understanding of the content incorporated. Return completed form within five (5) business days to the firm.
Quantity in Commerce170
DistributionUS: CA, IA, and VA
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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