Z-1365-2022Class II

Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

Name: Z-1365-2022 Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Creator: Draeger Medical Systems, Inc.
Published: 2022-05-20
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2022-05-20 / Open, Classified

FDA source

Draeger Medical Systems, Inc. began a recall of Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system on 2022-05-20. FDA classified it as Class II and gives the reason as "The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1365-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-20
Posted: 2022-07-12
Recalling firm: Draeger Medical Systems, Inc.
Product: Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Product code: FPL Incubator, Neonatal Transport
Reason for recall: The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
FDA root cause: Under Investigation by firm
Action: On May 20, 2022, the firm began to send Important Field Safety Notice letters to affected customers. Customers were instructed to avoid using the ventilator portion of the system due to the potential for enriched ambient air rising beyond safe levels until a replacement part can be installed and tested. The firm will send customers a replacement kit and testing which will be completed at no charge to the customer. Draeger Service Representatives will call customers and schedule a service visit to update affected systems.
Quantity in commerce: 38 OUS (no US distribution)
Distribution: No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW.
Product codes and lots: Model, country, and serial number: MS20508: El Salvador DSPN-0003 Mexico DSPM-0003, DSPH-0002 Chile DSPL-0003 Saudi Arabia DSPJ-0003, DSPL-0004, DSPL-0005, DSPL-0006, DSPL-0007, DSPM-0001, DSPM-0002, DSPL-0008, DSPK-0002, DSPH-0003, DSPJ-0004, DSRA-0001 Kuwait DSPJ-0002, DSPK-0001 India DSPN-0001, DSPN-0002, DSRA-0002 Taiwan DSPL-0001, SPL-0002, DSPJ-0001 MS20509: Germany DSPH-0003 Qatar DSPL-0007, DSRB-0001 Spain DSPK-0002, DSPJ-0006, DSPJ-0003, DSPH-0001, DSPJ-0004, DSPK-0001, DSPL-0008 Hungary DSPF-0003 Belarus DSPJ-0005 United Kingdom DSPF-0002 Italy DSPJ-0002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1365-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1365-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-11

Product code FPL

K141565Class IIGlobe-Trotter Gt5400Draeger Medical Systems, Inc. / cleared 2014-09-10

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)