Baxter announced a voluntary recall of 2 lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II). The recall is due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter that were identified during the manufacturing process.
Dianeal is a peritoneal dialysis (PD) solution for use in chronic renal failure patients being maintained on PD therapy. An intraperitoneal administration of particulate matter may result in inflammation with foreign body reaction or result in adhesion formation. Also, a potentially fatal infection could develop from the particulate matter if any pre-existing peritonitis exists.
The affected lots are as follows: #C940700 (exp. 5/31/16) and #C940841 (exp. 5/31/16). They were distributed to customers between May 30–July 9, 2014. Healthcare providers who received the affected product should return it for credit. The unaffected lots of product are also available for replacement.
For more information call (888) 229-0001 or visit the FDA.gov.