Class I Recall Issued for Draeger VentStar Resus Neo Breathing Circuits
The United States Food and Drug Administration has classified the removal of specific VentStar Resus Neo breathing circuits by Draeger as a Class I recall, denoting the most serious risk level. The action is due to the potential for obvious cracks to develop in the hose, which can cause the tubing to fall off or leak, leading to restricted ventilation, delayed therapy, desaturation, hypoxia, or patient death. Affected devices include model MP00310.
Draeger has instructed customers to carefully inspect these hoses for any signs of damage prior to use, following the product instructions. Any products showing cracks or detached hoses must be discarded immediately rather than returned. No serious injuries or deaths have been reported so far in connection with this issue.
Key points
- Draeger initiated a recall of VentStar Resus Neo hoses, model MP00310, due to potential cracking and detachment.
- Cracked or leaking hoses can cause restricted ventilation, leading to hypoxia, desaturation, or death.
- Clinicians are advised to inspect hoses prior to use and discard any damaged or cracked units.
- The FDA classified this action as a Class I recall.
What it means for you
Healthcare professionals and clinical staff utilizing neonatal respiratory equipment should carefully inspect VentStar Resus Neo hoses before each use and discard any units with cracks or detached components. Clinicians in Pakistan should check with local suppliers or the Drug Regulatory Authority of Pakistan to confirm the presence of these specific affected devices in local inventories and obtain any relevant guidance.
Breathing Circuit Recall: Draeger Removes VentStar Resus Neo Hoses
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.