FDA Device recall Z-1221-2019
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is…
- FDA Device
- Class III
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class III recall of Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is… by Getinge Us Sales, citing edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1221-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-20 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Getinge Us Sales |
| Distribution | US |
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
Identifiers
| code_info | Lot Number: 92265355 UDI Code: 6685775: 07325710002100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1221-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.