Recall Z-1365-2022 ยท FPL Incubator, Neonatal Transport
Draeger Medical Systems, Inc.
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
| Date | May 20, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141565 | GLOBE-TROTTER GT5400 Draeger Medical Systems, Inc., Sep 10, 2014 |