Early Alert: Compact Medical Recalls and Updates Use Instructions for ButterflyBVM Devices
The US Food and Drug Administration has issued an early alert regarding an urgent medical device recall and correction initiated by Compact Medical for certain lots of ButterflyBVM Single-Use Bag-Valve-Mask Resuscitators. The action was prompted because rare situations may cause a hole to develop in the device bellows, leading to air leaks, inadequate ventilation, and potential hypoxia or other serious injuries.
Affected products include specific lots designated for removal and others designated for continued use with updated instructions. For units marked for removal, users are advised to ensure a replacement bag-valve-mask is available before stopping use and quarantining the affected devices. For units requiring correction, users must perform a pre-use test before every application and immediately switch to a backup device if any failure or hole is detected.
Key points
- Compact Medical is recalling specific lots of ButterflyBVM resuscitators and updating instructions for other lots due to a risk of holes developing in the bellows.
- A compromised bellows can cause tidal volume to leak, resulting in inadequate ventilation and hypoxia for the patient.
- Affected devices designated for removal must be taken out of service once a replacement is secured and labeled as do not use.
- Units designated for correction require a pre-use test before every application, and backup resuscitators should always be kept available.
What it means for you
Clinicians and healthcare facilities should check their inventories for the affected ButterflyBVM lots to determine whether devices require removal or strict pre-use testing and corrections. Always ensure that functional backup bag-valve-mask resuscitators are immediately accessible in all patient care areas. Local healthcare providers should verify device availability and consult national regulatory authorities such as DRAP for any specific guidance regarding imported medical devices.
Early Alert: Compact Medical Removes and Updates Use Instructions for ButterflyBVM Bag-Valve-Mask Resuscitators
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.