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.
FDA Recall Z-1221-2019 · Posted None
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Recalling FirmGETINGE US SALES LLC
Recall StatusTerminated
Product CodePIF
Date Initiated2019-03-20
Date Terminated2020-04-08
Product Quantity17 boxes (5 catheters per box)
Reason for Recall
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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