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

Recalled May 1, 2019 · FDA recall Z-1221-2019 · GETINGE US SALES

Hazard

Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes · FDA Class III

Units

17 boxes (5 catheters per box)

Sold at

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

Description

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

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.

Manufacturer(s)

GETINGE US SALES LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →