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Philips recalls potential cancer-causing sleep apnea devices, ventilators in India
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Philips to recall impacted breathing devices, ventilators over health safety issues in India
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Philips India to recall impacted breathing devices, ventilators over health safety issues
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4 May 2021
Becton Dickinson (BD) has identified an issue with specific lots of BD Venflon Pro Safety (VPS) Needle Protected IV Cannulae after identifying an increase in reports of leakage from the injection port.
BD has issued an updated Field Safety Notice (FSN) and is recalling all products sterilised by ethylene oxide (EtO). It does not affect products sterilised by electron beam. Check the FSN for affected product codes and details on how to identify sterilisation methods used.
Risk involved with using affected product
There is a risk of blood or fluid loss from the injection port, which can result in serious harm if undetected.
Instructions for Medical Device Safety Officer/Medicines Safety Officer: Please circulate/forward to relevant departments
The manufacturer (Diffuplast) has identified a potential issue with their third-party sterilisation provider, which means that while a sterilisation process has been carried out and the devices are likely to be sterile, they have not been sterilised to the usual standard. However, the risk to patients is very low and therefore patients should continue to use their products as normal.
However, note that only the following products listed on this FSN are supplied in the UK:
Exacta Mix parenteral nutrition bags (see FSN for specific product codes and batch numbers)