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Sleep-Safe Set, Sleep-Safe Set Plus and Sleep-Safe Paed
Official notice
10 Jan 2017
Last checked
10 Jan 2017
An official ACCC notice concerns Sleep-Safe Set, Sleep-Safe Set Plus and Sleep-Safe Paed. 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). Published 2017-01-10.
What to do now
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.
Recall number
27da94a6-1bc5-41ea-adff-604daed3d2c2
Official notice
2017-01-10
The hazard
The 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).
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
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Source & status
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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