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