MiniCaps with povidone-iodine solution (used in peritoneal dialysis)

Related information

Recall for product correction - risk of peritonitis due to separated, partially protruding or missing sponge

6 February 2015

Consumers and health professionals are advised that Baxter Healthcare, in consultation with the TGA, has initiated a recall for product correction for its MiniCaps with povidone-iodine solution.

MiniCaps are used during peritoneal dialysis, a process which removes toxins and waste products from the bodies of people with kidney disease. These products can be used in hospitals and by patients for self-treatment in their homes.

It has been identified that MiniCaps may have been supplied with the sponge that provides sterility protection either fully separated, partially protruding or missing.

image of the sponch separated from the cap and next image is of the sponge prodruding from the cap

Using MiniCaps for which the sponge is fully separated or missing from the cap can compromise sterility protection at the end of automated peritoneal dialysis or continuous ambulatory peritoneal dialysis. This may increase the risk of peritonitis, which is inflammation of the membranes of the abdominal wall and organs. Peritonitis can be life-threatening and requires prompt medical treatment.

Information for consumers

Baxter Healthcare has contacted the suppliers (primarily hospitals) of MiniCaps with povidone-iodine solution to provide further information about this issue and instructions to contact affected patients.

If you or someone you care for uses MiniCaps, you should inspect the MiniCap pouch and the product itself before each exchange. If the sponge is separated, partially protruding or missing from the cap, do not use it and obtain a new MiniCap.

Please note that these products are not being recalled. If the sponge is not separated, partially protruding or missing from the cap, then it is safe to use.

To arrange replacement of affected MiniCaps, or if you have any questions or concerns about this issue, contact Baxter Healthcare on 1300 789 646.

Information for health professionals

Baxter Healthcare has contacted the suppliers (primarily hospitals) of MiniCaps with povidone-iodine solution to provide further information about this issue and instructions to contact affected patients.

If you are treating a patient who uses MiniCaps 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.