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U.S. Department of Health and Human Services

Class 3 Device Recall ServoI Ventilator System EDI CATHETER

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  Class 3 Device Recall ServoI Ventilator System EDI CATHETER see related information
Date Initiated by Firm March 20, 2019
Create Date April 25, 2019
Recall Status1 Terminated 3 on April 08, 2020
Recall Number Z-1221-2019
Recall Event ID 82533
510(K)Number K153688  
Product Classification Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Product Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg
Product Code/REF Number: 6685775
Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.
Code Information Lot Number: 92265355 UDI Code: 6685775: 07325710002100
Recalling Firm/
Manufacturer		 GETINGE US SALES LLC
45 BARBOUR POND DR
WAYNE NJ 07470
Manufacturer Reason
for Recall		 Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
FDA Determined
Cause 2		 Under Investigation by firm
Action Maquet issued letters to customers on March 20, 2019 via FedEx Standard Overnight states issue, health risk and action to take: remove product and contact Getinge Customer Service at 1-888-627-8383 (press option 2, then option 3) to request a return authorization (RMA) and shipping instructions to return any affected product. Questions please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 3), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.
Quantity in Commerce 17 boxes (5 catheters per box)
Distribution Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
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 = PIF and Original Applicant = MAQUET CRITICAL CARE AB
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