Medical device manufacturer, Becton Dickinson (BD) has issued a medical device safety alert to recall its Infusion Sets for Alaris Pumps (GP, VP, CC, GW/GW800, SE, IVAC 590 series) and Gravity Infusion Sets & Connectors.
The manufacturer has been notified by a 3rd party sterilisation services provider that it intentionally falsified sterilisation process records related to the processing of BD products. The manufacturer is unable to guarantee the sterility of the devices. Therefore, it is removing the devices from the market.
According to the manufacturer, the use of non-sterile devices in the clinical setting could lead to an increased risk of infection which may cause serious harm or life-threatening conditions. The manufacturer has not identified any reports of adverse events or serious patient harm to date. Specific patient follow-up activities are not required if the product has already been used.
Impacted lot numbers can be identified using the manufacturer's online tool located at: bd.com/MDS-21-4072. For details, please refer to the following link: https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-supply-disruption -of-sterile-infusion-sets-and-connectors-manufactured-by-becton-dickinson-bd-natpsa -slash-2021-slash-001-slash-mhra
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 12 March 2021