Z-1221-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- March 20, 2019
- Termination Date
- April 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 boxes (5 catheters per box)
Product 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.
Reason for Recall
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Distribution Pattern
Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
Code Information
Lot Number: 92265355 UDI Code: 6685775: 07325710002100