The Recall Desk
HighFDA (Devices)·Z-1365-2022·Announced 2022-07-20

Neonatal Transport System Oxygen Supply Component Pressure-Rating Defect

Draeger Medical is recalling neonatal transport systems because an oxygen supply component is not rated for the system's working pressure. This affects 38 units distributed internationally but not in the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for a pressure-rating defect in a neonatal oxygen delivery system. With no reported illnesses, injuries, or deaths, the severity is classified as High based on the risk-of-harm nature of the product and the critical patient population served.

Plain-English summary

Draeger Medical Systems, Inc. is recalling neonatal transport systems with model numbers MS20508 and MS20509 (Draeger Globe-Trotter and Draeger Globe-Trotter IC). These devices are designed to transport newborns requiring medical care.

A component within the oxygen supply system is not rated to the system's working pressure. The manufacturer initiated this recall to replace the defective component.

The recall affects 38 units distributed internationally but not in the United States. Affected units were distributed to Belarus, Chile, Germany, El Salvador, Hungary, India, Italy, Kuwait, Mexico, Qatar, Saudi Arabia, Spain, Taiwan, and the United Kingdom. Healthcare facilities that received these devices should contact Draeger Medical Systems, Inc. for instructions on obtaining replacement components.

The recalled product

Product
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Manufacturer
Draeger Medical Systems, Inc.
Hazard
  • oxygen-system-defect
  • pressure-rating-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 2 states:

  • DE
  • IN