Advisory - Baxter recalls two lots of Extraneal peritoneal dialysis solution because of high levels of sodium hypochlorite, which may pose serious health risks
OTTAWA, March 23, 2019 /CNW/ - Health Canada is advising Canadians that Baxter Corporation is voluntarily recalling two lots of Extraneal peritoneal dialysis solution as a precautionary measure because of high levels of sodium hypochlorite.
Use of the affected product in patients could cause chemical peritonitis. Chemical peritonitis is inflammation of the peritoneum (the lining of the abdomen and pelvis), which can be serious if not promptly treated. Symptoms include nausea, vomiting, and abdominal pain or tenderness. The high levels of sodium hypochlorite are found in the active pharmaceutical ingredient icodextrin, and can cause discolouration of the solution.
Extraneal is a sterile peritoneal dialysis solution used for patients whose kidneys are not working properly. The dialysis solution is used in hospitals and home settings. The lots affected by this recall were distributed by Baxter between March 14, 2019 and March 20, 2019.
Who is affected Canadians who have product from the affected lots
Affected products
Product
DIN
Product Code
Lot
Expiry
Extraneal 2L/2L Twinbag
02240806
JB9912
W9B28T0
02/29/2020
Extraneal 7.5% 2.5L SYSII
02240806
JB9923LP
W9C05T1
03/31/2020
What consumers should do
Immediately examine your stock to determine whether you have product from the affected lot. The product code and lot number can be found on the individual product or shipping carton.
If you have affected product, speak to your healthcare provider immediately regarding replacement product.
Contact Baxter Corporation Customer Care at 1-866-968-7477 for instructions on how to return the recalled product.
Talk to your doctor or nurse if you have used product from the affected lot.
What Health Canada is doing Health Canada is monitoring the recall. Should Health Canada become aware of additional safety information, it will take appropriate action and inform Canadians as necessary.
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