The company was alerted to an issue with the syringe pumps that could cause risk of under-infusion and/or alarm failure, according to the notice published today.
Users of the syringe pumps are urged to follow instructions for the pumps and to immediately stop using it if white plastic debris is spotted on the lead screw. If the debris is seen, users are instructed to send the pump to BD or a chosen service provider for repair and to regularly check that the pump is running as expected.
The notice also instructs users to cease use of the device if an alternative infusion pump is available, although Medicines and Healthcare products Regulatory Agency (MHRA) said it is aware that this isn’t practical in some cases. Actions are ordered to be underway by March 17 and completed by March 31.
BD is currently in the process of releasing a new design for the lead screw. Once released, the lead screw component is slated to be replaced for all of the pumps on the market.