CLASS I Device recall · Reported 24 May 2023 · FDA Enforcement Report
VentStar breathing bag Set (P) 110, MP00384 recalled by Draeger Medical
Draeger Medical is recalling VentStar breathing bag Set (P) 110, MP00384, distributed nationwide in the US. The recall was initiated on 17 Apr 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1445-2023
- FDA event ID
- 92049
- Recalling firm
- Draeger Medical, Telford, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Apr 2023
- FDA classified
- 17 May 2023
- Reported
- 24 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Apr 2023 | Recall initiated by company | |
| 17 May 2023 | Classified by FDA | +30 days |
| 24 May 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product as listed by the FDA
VentStar breathing bag Set (P) 110, MP00384
Where it was distributed
Domestic: US Nationwide Distribution.
Questions about this recall
Why was it recalled?
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Which lots are affected?
UDI-DI: 04048675421870; All lots.
Where was it sold?
Domestic: US Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
21 other products · FDA event 92049This product is part of a recall event; the main page for the event is VentStar Basic (P)180, MP00351 recalled by Draeger Medical.
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