Recall Z-1365-2022— Draeger Medical Systems, Inc.

Name: FDA recall Z-1365-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-20

Class II · Ongoing

Class II FDA medical device recall by Draeger Medical Systems, Inc., initiated 2022-05-20. It names one FDA 510(k) clearance: K141565. Product: Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system. 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..

Recalling firm: Draeger Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-05-20
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K141565 — GLOBE-TROTTER GT5400Draeger Medical Systems, Inc.·cleared 2014-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.