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U.S. Department of Health and Human Services

Class 2 Device Recall CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kit

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  Class 2 Device Recall CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kit see related information
Date Initiated by Firm October 08, 2019
Create Date November 14, 2019
Recall Status1 Terminated 3 on March 16, 2022
Recall Number Z-0370-2020
Recall Event ID 84021
510(K)Number K882867  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case

The devices could be branded as Halyard Health.
Code Information Catalog Number: 30-4020 (Lot Numbers:0203145253, 0203081127);   Catalog Number: 30-4320 (Lot Numbers: 0002994173, 0202974008, 0202907370, 0203201718, 0203241065)
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Thomas Kozma, Ph.D.
470-448-5861
Manufacturer Reason
for Recall		 The connector piece to the PEG tube does not pass over the guidewire.
FDA Determined
Cause 2		 Under Investigation by firm
Action Avanos Medical notified customers of the recall on about 10/08/2019, via "URGENT: PRODUCT RECALL" letter. Customers were informed that there is a potential where the PEG tube does not pass over the guidewire. Instructions included to evaluate your inventory for any affected products, discontinue use of any affected product, quarantine any on hand, and arranged for the return of affected product. Customers were also instructed to complete the provide Recall Acknowledgement Form (Attachment 1) and return a copy of the form to Avanos in the USA by email to avanos4178@stericycle.com or by FAX to 1-888-807-1084. Outside the USA, please send by email to avanos4178OUS@stericycle.com or by FAX to +44 (0) 20 7660 1462. For further assistance, please contact Avanos by email at avanos4178@stericycle.com or by FAX to 1-888-807-1084. Outside the USA, please send by email to avanos4178OUS@stericycle.com or by FAX to +44 (0) 20 7660 1462. You may also contact Avanos Customer Service at exportcustomercare@avanos.com.
Quantity in Commerce 104 cases (208 units) total
Distribution Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
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 = KNT and Original Applicant = CORPAK CO.
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