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.
Enforcement
- Recall Number
- Z-1221-2019
- Event ID
- 82533
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- GETINGE US SALES LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 1, 2019
- Initiation Date
- March 20, 2019
- Classification Date
- April 25, 2019
- Termination Date
- April 8, 2020
- Address
- 45 BARBOUR POND DR, N/A, WAYNE, NJ, 07470, United States
Description
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.
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Lot Number: 92265355 UDI Code: 6685775: 07325710002100
Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
17 boxes (5 catheters per box)