Medical device manufacturer, Baxter Healthcare, has issued a field safety notice concerning its Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells. The concerned product codes are 5C4160, 5C4482, 5C4129, SPC4213, 5C4215P and 6AC4466H.
The manufacturer provides an important safety update to the instruction for use (IFU) for the concerned products. Specifically, the manufacturer is adding a contraindication statement to address iodine allergy for the manufacturer's peritoneal dialysis products which contain iodine (i.e. povidone iodine) or for which iodine use is recommended.
For patients sensitive to iodine, the use of products which contain iodine or for which iodine use is recommended could result in a contact allergy or an adverse reaction if it enters the peritoneal cavity.
According to the local supplier, Baxter Healthcare (Hong Kong), the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 23 April 2014