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U.S. Department of Health and Human Services

Class 2 Device Recall CORFLO, PEG

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  Class 2 Device Recall CORFLO, PEG see related information
Date Initiated by Firm February 03, 2017
Create Date May 25, 2017
Recall Status1 Terminated 3 on August 05, 2019
Recall Number Z-2163-2017
Recall Event ID 76465
510(K)Number K882867  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product CORFLO PEG Kit, Pull 16FR.

Product Usage:
CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Code Information Catalogue Numbers: 50-6016
Recalling Firm/
Manufacturer		 CORPAK MedSystems, Inc.
1001 Asbury Dr
Buffalo Grove IL 60089-4528
For Additional Information Contact
847-403-3400
Manufacturer Reason
for Recall		 Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
FDA Determined
Cause 2		 Device Design
Action Firm provided consignees with field correction on 2/2/2017 by letter mailed via FedEx. Within the notice, the firm provided additional instructions for handling the PEG Y-Adapter to help reduce the likelihood for exposing the stem to excess stress that could break the connector. Consignees were instructed to forward the field correction notice to all staff members or end-users who use the ENFit Y-Adapter.
Quantity in Commerce 8 cases (2 units per case)
Distribution Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
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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