Recall Z-1460-2023— Draeger Medical, Inc.

Class I · Terminated

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2023-04-17, terminated 2024-09-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Anesthesia Circuit Kit Coax HEPA, MP17102. Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces..

Recalling firm
Draeger Medical, Inc.
Classification
Class I
Status
Terminated
Initiated
2023-04-17
Terminated
2024-09-03
Firm location
Telford, PA, United States

Product description

Anesthesia Circuit Kit Coax HEPA, MP17102

Reason for recall

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

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