CLASS I Device recall · Reported 30 Jan 2019 · FDA Enforcement Report
VentStar Basic recalled by Draeger Medical
Draeger Medical is recalling VentStar Basic 250, distributed in 12 states. The recall was initiated on 21 Dec 2018 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-0737-2019
- FDA event ID
- 81874
- Recalling firm
- Draeger Medical, Telford, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Dec 2018
- FDA classified
- 24 Jan 2019
- Reported
- 30 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 21 Dec 2018 | Recall initiated by company | |
| 24 Jan 2019 | Classified by FDA | +34 days |
| 30 Jan 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Product as listed by the FDA
VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
Where it was distributed
US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.
AlabamaCaliforniaColoradoConnecticutFloridaKentuckyMichiganNew JerseyOhioPennsylvaniaSouth CarolinaTexas
Questions about this recall
Is VentStar Basic 250 recalled?
Yes. Draeger Medical recalled VentStar Basic 250 on 21 Dec 2018. The recall is Class I and its status is Terminated. Recall number Z-0737-2019.
Why was it recalled?
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Which lots are affected?
All Lots
Where was it sold?
US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Draeger Medical
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|---|---|---|---|---|---|
| Device | CLASS I | Atlan A300 recalled by Draeger Medical | Draeger Medical | Device Malfunction | PA |
| Device | CLASS I | Atlan A300XL recalled by Draeger Medical | Draeger Medical | Device Malfunction | PA |
| Device | CLASS I | Atlan A350 recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Atlan A350XL recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Dr¿ger Perseus A500 Anesthesia Workstation recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
All 551| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
| Device | CLASS I | Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | WI |