Sleep-Safe Set, Sleep-Safe Set Plus and Sleep-Safe Paed
Published 10 January 2017
Product
Affected Batch Numbers: Sleep-Safe Set XAS131 XCS241 Sleep-Safe Set Plus XBS011 XBS252 XBS253 XCS221 XES09100 XES10100 XES12100 XES17100 XES31100 Sleep-Safe Set Paed XAS221 XBS043
Why it was recalled
The products may experience leakage caused by over welded coils, which can lead to difficulties in unrolling the tubing that can create pinholes in the lines. The damage may not be visible and will not be detected by the system's Sleep-Safe cycler.
Hazard
If this occurs, there is a risk of the patient developing an infection, such as peritonitis (inflammation of the membranes of the abdominal wall and organs).
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.