Z-1221-2019Class III

Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775

Name: Z-1221-2019 Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775
Creator: Getinge US Sales Llc
Published: 2019-03-20
License: https://open.fda.gov/license/

Getinge US Sales LLC / initiated 2019-03-20 / Terminated / root cause: labeling and UDI

FDA source

GETINGE US SALES LLC began a 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 a single-use... on 2019-03-20. FDA classified it as Class III and gives the reason as "Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1221-2019
Classification: Class III
Status: Terminated
Initiated: 2019-03-20
Posted: 2019-04-25
Terminated: 2020-04-08
Recalling firm: Getinge US Sales LLC
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.
Product code: PIF Gastrointestinal Tubes With Enteral Specific Connectors
Reason for recall: Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Maquet issued letters to customers on March 20, 2019 via FedEx Standard Overnight states issue, health risk and action to take: remove product and contact Getinge Customer Service at 1-888-627-8383 (press option 2, then option 3) to request a return authorization (RMA) and shipping instructions to return any affected product. Questions please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 3), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.
Quantity in commerce: 17 boxes (5 catheters per box)
Distribution: Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
Product codes and lots: Lot Number: 92265355 UDI Code: 6685775: 07325710002100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1221-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1221-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-25

Product code PIF

K153688Class IIEdi Catheter ENFitMaquet Critical Care AB / cleared 2017-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)