The Recall Desk
SevereFDA (Devices)·Z-1439-2023·Announced 2023-05-24

Draeger Medical Seattle PAP Plus breathing circuit connections may detach during use

Draeger Medical is recalling the Seattle PAP Plus due to glued breathing circuit connections that may loosen or completely detach during ventilation, potentially interrupting airflow.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This FDA Class I recall involves a critical respiratory medical device where mechanical connection failures could interrupt ventilation during patient use. Per FDA classification standards, Class I recalls never fall below Severe (4). No deaths or injuries have been reported in the source material.

Plain-English summary

Draeger Medical, Inc. is recalling the Seattle PAP Plus, Model MP02260, across the United States. The breathing circuit connections in these devices are glued and can become loose before or during ventilation, resulting in partial or complete detachment of pieces.

A loose or detached breathing circuit connection could interrupt airflow during ventilation. This recall affects all units distributed before March 20, 2023, except for lot 0367.2702.13. Approximately 32,050 units are affected nationwide.

Patients and healthcare providers using this device should discontinue use and contact Draeger Medical for replacement or repair options. Any adverse events related to this device should be reported to Draeger Medical and the FDA.

The recalled product

Product
Seattle PAP Plus, MP02260
Manufacturer
Draeger Medical, Inc.
Hazard
  • connection-detachment
  • airway-obstruction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI: 04048675548904
  • All lots distributed prior to 03/20/2023 (lots other than 0367.2702.13).

Distribution

Distributed nationwide across the United States.