Recall Z-1221-2019

Product type

Devices

Firm

GETINGE US SALES LLC

Status

Ongoing

Classification

Class III

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.

Reason

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

Distribution

Worldwide distribution -

Report date

2019-05-01