medical Class III Updated 2019-05-01

GETINGE US SALES LLC recalls Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/

Recalled 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.


Hazard / Issue

Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 92265355 UDI Code: 6685775: 07325710002100
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →