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.
This recall has been terminated (originally issued March 20, 2019).
- Company
- Getinge Us Sales Llc
- Recall Initiated
- March 20, 2019
- Terminated
- April 8, 2020
- Recall Number
- Z-1221-2019
- Quantity
- 17 boxes (5 catheters per box)
- Firm Location
- WAYNE, NJ
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot Number: 92265355 UDI Code: 6685775: 07325710002100
Root Cause
Under Investigation by firm
Action Taken
Maquet issued letters to customers on March 20, 2019 via FedEx Standard Overnight states issue, health risk and action to take: remove product and contact Getinge Customer Service at 1-888-627-8383 (press option 2, then option 3) to request a return authorization (RMA) and shipping instructions to return any affected product. Questions please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 3), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.