A supplier was found to be falsifying sterilisation records.
Million of IV giving sets and connectors are being recalled by their manufacturer after a supplier falsified sterilisation documents going back ten years.
Becton Dickinson (BD) has officially notified the Medicines and Healthcare products Regulatory Agency (MHRA) that the sterility of some of its devices cannot be guaranteed after a supplier was found to have intentionally falsified sterilisation process records.
BD is now recalling all infusion sets for CC, GP, VP, GW/GW800, SE, and IVAC 590 Alaris Pumps and gravity infusion sets and connectors
Healthcare professionals are now being advised by the MHRA to use alternative pumps and giving sets or alternatives to intravenous infusion where they are available, and it is safe to do so.
The MHRA said that while there has been a small number of reported incidents about IV giving sets there is no evidence of infections caused by the devices.
A shortage of IV infusion sets is expected to last for several weeks.
Initiated a full recall.
BD say they acted as soon as they were made aware of the issue and are working to resupply hospitals as quickly as possible.
They said: “BD has confirmed that records related to its products had been intentionally falsified. While BD has not received customer complaints related to sterility, we cannot presume a product to be sterile if documentation is unreliable.
“In the interest of patient safety, BD has initiated a recall for all batches of products sterilised at this facility. We are also advising customers about potential alternate products when possible.
“BD customers deserve the highest quality and safest products available and the systemic and intentional falsification of records is unacceptable.
“We recognize this ship hold and recall will temporarily disrupt supply of these essential products, and we are currently qualifying another sterilisation facility in Europe in order to restore supply as quickly as possible. BD expects supply of these products will progressively resume within the next few weeks.”
