Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Recalled by GETINGE US SALES LLC Due to Edi Catheter labeled with wrong expiry date on...

Date: March 20, 2019
Company: GETINGE US SALES LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GETINGE US SALES LLC directly.

Affected Products

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.

Quantity: 17 boxes (5 catheters per box)

Why Was This Recalled?

Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GETINGE US SALES LLC

GETINGE US SALES LLC has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report