Recall Z-1221-2019— GETINGE US SALES LLC
Class III · Terminated
Class III FDA medical device recall by GETINGE US SALES LLC, initiated 2019-03-20, terminated 2020-04-08. It names one FDA 510(k) clearance: K153688. 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.
- Recalling firm
- GETINGE US SALES LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-03-20
- Terminated
- 2020-04-08
- Firm location
- WAYNE, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.