National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA)
BD is recalling all affected stock of its infusion sets for specific Alaris Pumps, and gravity infusion sets & connectors, as their sterility cannot be guaranteed due to quality issues with their third-party sterilisation provider. Supply disruption is to be expected for 4 weeks
Source:
Medicines and Healthcare products Regulatory Agency
SPS commentary:
BD was notified by its sterilisation services provider that it intentionally falsified sterilisation process records related to the processing of BD products. Following an investigation, BD concluded that it was unable to guarantee the sterility of the devices listed in the FSN, and these are being removed from the market.
The accompanying Field Safety Notice (FSN) contains full lists of the impacted product catalogue numbers, and contains advice for clinical users.