# FDA recall Z-1221-2019

> **GETINGE US SALES LLC** · Class III · device recall initiated 2019-03-20.

## 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 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.

## Key facts

- **Recall number:** Z-1221-2019
- **Recalling firm:** GETINGE US SALES LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-20
- **Report date:** 2019-05-01
- **Termination date:** 2020-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** WAYNE, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1221-2019

## Citation

> AI Analytics. FDA recall Z-1221-2019. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1221-2019. Source: US FDA. Licensed CC0.

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