Consumers and health professionals are advised that Baxter Healthcare, in consultation with the TGA, is undertaking a recall of one lot of its MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp.
These transfer sets are used to move fluids during peritoneal dialysis, a process which removes toxins and waste products from the bodies of people with kidney disease.
Peritoneal dialysis involves pumping a fluid into and out of the abdomen. Toxins and waste products dissolve into the fluid and are removed from the body.
There have been reports of connection issues in procedures using transfer sets from lot H12F18054.
These connection issues may lead to fluid leaks and the potential for contamination of the fluid being used.
Such contamination has the potential to lead to peritonitis, a serious condition.
Information for consumers
Baxter Healthcare has contacted the suppliers (primarily hospitals) of the MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp to provide further information about the recall and instructions to contact affected patients.
If you are a patient or carer using a MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp you should attempt to locate the lot number on the product packaging. If you have product from the affected lot (H12F18054) or cannot locate a lot number, contact your hospital or treat health professional for further information and advice.
If you have any questions or concerns, you can contact Baxter Healthcare on 1300 789 646 during office hours.
Information for health professionals
Baxter Healthcare has contacted the suppliers (primarily hospitals) of the MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp to provide further information about the recall.
If you are treating a patient who uses a MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp and they have any questions or concerns about this issue, advise them to contact Baxter Healthcare on 1300 789 646 during office hours.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.