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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Affected units
- 32,050
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.
Part of a larger recall action
This product is one of 22 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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