Recall Z-1439-2023— Draeger Medical, Inc.

Name: FDA recall Z-1439-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-17

Class I · Terminated

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2023-04-17, terminated 2024-09-03. It names one FDA 510(k) clearance: K131502. Product: Seattle PAP Plus, MP02260. 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

510(k) clearances named in this recall

1 on FDA's record

K131502 — SEATTLE - PAPSeattle Childrens Hospital·cleared 2013-10-11

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

Seattle PAP Plus, MP02260

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.