PRA number
2017/15835
Published date
Product description
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
Sleep-Safe Set
XAS131
XCS241
Sleep-Safe Set Plus
XBS011
XBS252
XBS253
XCS221
XES09100
XES10100
XES12100
XES17100
XES31100
Sleep-Safe Set Paed
XAS221
XBS043
Reasons the product is 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.
The hazards to consumers
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).
What consumers should do
If you or someone you provide for care for uses Sleep-Safe tubing sets, you should be contacted by the peritoneal dialysis unit at your hospital or your Fresenius Medical Care Australia representative to arrange replacement of affected products.
While you are awaiting replacement lines, you can continue to use the products you have in accordance with the correct handling instructions.
In particular, remember to:
• unroll Sleep-Safe tubing sets carefully
• discard the sets if unrolling is not possible
• if unrolling is successful, carefully check the patient line for leakages during priming.
If you think you have affected products but have not been contacted, or if you have any questions or concerns about this issue, contact the peritoneal dialysis unit at your hospital, your Fresenius Medical Care Australia representative or Fresenius Medical Care Australia on 02 9466 8048.
While you are awaiting replacement lines, you can continue to use the products you have in accordance with the correct handling instructions.
In particular, remember to:
• unroll Sleep-Safe tubing sets carefully
• discard the sets if unrolling is not possible
• if unrolling is successful, carefully check the patient line for leakages during priming.
If you think you have affected products but have not been contacted, or if you have any questions or concerns about this issue, contact the peritoneal dialysis unit at your hospital, your Fresenius Medical Care Australia representative or Fresenius Medical Care Australia on 02 9466 8048.
Supplier
Fresenius Medical Care Australia
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.