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Open, Classified

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

FDA Recall Z-1365-2022 · Posted None

Recalling FirmDraeger Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodeFPL
Date Initiated2022-05-20
Product Quantity38 OUS (no US distribution)

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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