Surgical manifolds recalled from UK hospitals due to microplastic contamination

MEDICAL devices used to control fluids in some surgical procedures have been urgently recalled after plastic particulates were found inside fluid pathways. 

Medline Industries said that around 1,100 manifolds out of nearly 2m it has manufactured for surgical procedure packs could be impacted by the plastic particulates, and has alerted users of the batch codes of affected devices. The defect was caused by plastic from the manifold handle shearing, depositing particulates into the fluid pathway, and was identified in “routine visual inspection”. The particulates measured 0.19-0.25 mm², classifying them as a microplastic. The defect could have led to embolisms and, in rare instances, death, according to the UK Medicines and Healthcare Products Regulatory Agency (MHRA). 

Shortly after the manifold recall was issued last week, Medline issued another urgent recall of syringes in the same procedure packs, saying they could unscrew, putting patients at risk of biohazard exposure, blood loss, infection and air embolism, potentially resulting in serious injury or death, according to the MHRA.   

The MHRA said there have so far been no reported embolisms or injuries caused by either of the defects. 

Both the manifolds and syringes were part of procedure packs made by Kimal, primarily used for diagnostic and interventional cardiology and radiology procedures. The manifolds are designed for fluid management, invasive pressure monitoring, and intra-arterial or intra-venous administration of water-based solutions or radiographic contrast media. Replacement manifolds are expected to be available from June, although this is not guaranteed. Medline advised healthcare staff that faulty manifolds should be used only in “urgent procedures where there are no alternatives” and “where delaying the procedure would place the patient at significantly increased risk”. 

Medline has also advised that faulty manifolds must be flushed with sterile saline before use to ensure there are no particulates.