GETINGE US SALES LLC: Medical Device Recall in 2019 - (Recall #: Z-1221-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: March 20, 2019

Date Posted: May 1, 2019

Recall Number: Z-1221-2019

Event ID: 82533

Reason for Recall:

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

Status: Terminated

Product Quantity: 17 boxes (5 catheters per box)

Code Information:

Lot Number: 92265355 UDI Code: 6685775: 07325710002100

Distribution Pattern:

Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.

Voluntary or Mandated:

Voluntary: Firm initiated