FDA recall Z-1221-2019

GETINGE US SALES LLC · Class III · device

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 for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-03-20
Report date
2019-05-01
Termination date
2020-04-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
WAYNE, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1221-2019