UK MHRA has issued a Medical Device Alert(MDA) relating to Vygon’s Octopus 3 (3 lumen catheter) extension set with antireflux valves and clamps, which have been identified as at possible risk of failure to deliver therapy under gravity infusion, as these sets may be fitted with antisyphon valves instead of anti-reflux valves.
The manufacturer issued a Field Safety Notice(FSN) for this device on 27/09/2011, but has not had sufficient confirmation from users that they have received and acted on this information, which has precipitated this MDA.
The Alert is limited to Product code: 0841361, Batch number: 080411AE
This is a product recall, so all potential recipients of these devices are asked to identify and quarantine any remaining stock and contact Vygon to arrange return and replacement.
The full MDA including contact details for return of goods can be found here.
The action is due for completion by January 24th 2012