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

FDA Device Recall #Z-1365-2022 — Class II — May 20, 2022

Recall Summary

Recall Number Z-1365-2022
Classification Class II — Moderate risk
Date Initiated May 20, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Draeger Medical Systems, Inc.
Location Telford, PA
Product Type Devices
Quantity 38 OUS (no US distribution)

Product Description

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

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.

Distribution Pattern

No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW.

Lot / Code Information

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

Other Recalls from Draeger Medical Systems, Inc.

Recall # Classification Product Date
Z-1066-2025 Class II Infinity Central Station. Model Number: MS26800... Jan 14, 2025
Z-2189-2024 Class II Infinity Acute Care System (IACS) Monitoring Sy... May 13, 2024
Z-1992-2023 Class II Draeger Softbed Resuscitaire and/or Birthing Ro... May 16, 2023
Z-1472-2023 Class II Draeger Infinity M300 and M300+, for use with t... Apr 5, 2023
Z-1471-2023 Class II Draeger Infinity CentralStation (ICS), centrali... Apr 5, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.