FDA recall Z-1365-2022

Draeger Medical Systems, Inc. · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2022-05-20
Report date: 2022-07-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1365-2022