| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00058-1 |
| Product Name/Description |
MiniCap with Povidone-Iodine Solution
Product Code: SPC4466
Expiration Date: All non-expired product
ARTG Number: 167416 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Baxter received complaints indicating that the Iodine sponge of the MiniCap was fully separated from the cap, partially protruding from the cap, or missing.
This may give rise to infusion of micro-organisms or by-products of microbes or other foreign materials into the peritoneal cavity, which may lead to bacterial or fungal peritonitis and/or infusion of inert foreign material into the peritoneal cavity which may lead to tissue injury or peritoneal membrane injury.
These events are considered as catastrophic, however, the likelihood of this occuring has been calculated by the Manufacturer as Improbable (Less than one in one million chance). |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are advised to inspect the product to ensure there is no damage to the MiniCap and that the sponge is fully within the cap. Do not use the product if the sponge is protruding or missing from the cap, and obtain a new MiniCap. For further information please see https://www.tga.gov.au/alert/minicaps-povidone-iodine-solution-used-peritoneal-dialysis. |
| Contact Information |
1300 789 646 - Baxter Healthcare Customer Service |