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Health Canada Health products

0.9% Sodium Chloride Injection, USP and Lactated Ringer’s Injection, USP - Potential Leak During Pressure Infusion

Issued March 9, 2022
Issue
Intravenous bags of Baxter’s 0.9% Sodium Chloride Injection, USP 500 mL and Lactated Ringer’s Injection, USP 500 mL from certain lots have the potential to leak when administered under pressure infusion due to a weak seal formation. Affected lots are not being recalled to prevent a shortage of these medically necessary products. Leakage from the bags could: lead to contamination of the solution and may result in a serious blood infection . Patients with an infection of the blood may develop a fever, low blood pressure, or an altered level of consciousness. Blood infections may be life-threatening in both adults and children. result in an inaccurate amount of medication being delivered when other medications have been mixed into the 0.9% Sodium Chloride Injection, USP 500 mL and Lactated Ringer’s Injection, USP 500 mL as part of routine treatments. expose healthcare professionals or patients handling the bags to hazardous medications (e.g., cytotoxic chemotherapeutic drugs) when these medications have been added to the bags.
Hazard description
Product quality - Product safety
Product
Product name
0.9% Sodium Chloride Injection, USP and Lactated Ringer’s Injection, USP
Reference
ID
RA-63973