Date Initiated by Firm |
February 03, 2017 |
Create Date |
May 25, 2017 |
Recall Status1 |
Terminated 3 on August 05, 2019 |
Recall Number |
Z-2161-2017 |
Recall Event ID |
76465 |
510(K)Number |
K882867
|
Product Classification |
Tubes, gastrointestinal (and accessories) - Product Code KNT
|
Product |
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm);
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: 50-6112 |
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 |
2 cases (5 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
|
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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.
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510(K) Database |
510(K)s with Product Code = KNT and Original Applicant = CORPAK CO.
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