Draeger VentStar Resus Neo Neonatal Breathing Circuit Recall
Draeger is recalling VentStar Resus Neo neonatal breathing circuits due to potential hose cracks that could cause leakage or disconnection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that poses a risk of harm (leakage or disconnection) but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Draeger, Inc. is recalling the VentStar Resus Neo Neonatal disposable breathing circuits, Part Number MP00310. The recall covers 1,063,643 units distributed nationwide in the United States and in numerous countries internationally. The product is intended for use with a resuscitation module.
The recall is being issued because of potential cracks in the hose. These cracks could lead to leakage or the hose falling off during use. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users should stop using the affected breathing circuits and contact Draeger, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
- Manufacturer
- Draeger, Inc.
- Category
- Medical Device — Respiratory
- Hazard
- Affected units
- 1,063,643
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 (1)
- Part Number MP00310. UDIDI: 04048675422358. All lot numbers.
Distribution
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