GETINGE US SALES LLC recalls Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage:…

Recall date

March 20, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1221-2019

FDA classification

Class III

Brand / firm

GETINGE US SALES LLC

Sold / distributed

Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.