0.9% Sodium chloride injection, usp and lactated ringer’s injection, usp - potential leak during pressure infusion

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. Audience Healthcare professionals including physicians, nurses, pharmacists, and other medical and support personnel including home healthcare agencies involved in the administration and handling of 0.9% Sodium Chloride Injection, USP 500 mL and Lactated Ringer’s Injection, USP 500 mL products. Key messages 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. Leakage from the bags could: lead to contamination of the solution which may result in a serious blood infection. 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. 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. Healthcare professionals are advised of the following: Do NOT administer products from affected lots (see Appendix A) under pressure infusion. Regardless of the lot, prior to administration, tear the overwrap (outer bag) down the side at the slit and remove the inner bag. Inspect the bag for low fill volume and for leaked fluid in the space between the overwrap and inner bag. Check for minute leaks by squeezing the inner bag firmly. If any leakage is observed, the bag should be discarded due to the potential risk of contamination. Monitor for leakage from the bag during treatment and stop using if leakage is observed. In the affected lots, leaks are more likely to be found in the area highlighted in the photo in Appendix B. Gloves should be worn when handling the bags to avoid exposure to any hazardous medications that may have been added to the bags. Background 0.9% Sodium Chloride Injection, USP (DIN 00060208) is indicated as a source of water and electrolytes. It can also be used as a vehicle or diluent for compatible products for parenteral administration, or for use as a priming solution in hemodialysis procedures. Lactated Ringer’s Injection, USP (DIN 00061085) is indicated as a source of water and electrolytes or as an alkalinizing agent. Baxter identified the cause of the leakage of the 500 mL intravenous bags as a weak seal formation due to inappropriate manufacturing equipment set-up. Baxter has implemented corrective actions to prevent reoccurrence. There have been no reports of adverse events to date for the affected lots. Products from the affected lots were distributed by Baxter Corporation in Canada between May 21, 2021 and March 01, 2022. Information for consumers (home patients) Do NOT use the bags from affected lots in treatments where pressure is applied to the bags, as fluid may leak out. If you see any fluid leakage from the bags before or during treatment, stop using the product as there may be a potential risk of contamination and consult your healthcare professional. Gloves should be worn when handling the bag to avoid exposure to any toxic drugs (such as some cancer drugs) that may have been added to the fluid in the bags. If you use these products with pressure, and you have product from an affected lot, do NOT use the bags and consult your healthcare professional to obtain a replacement product as soon as possible. Consult with your healthcare professional if you have used product from an affected lot, or are unsure and have questions or concerns about your health. Information for healthcare professionals Bags of 0.9% Sodium Chloride Injection, USP 500 mL and Lactated Ringer’s Injection, USP 500 mL from the affected lots should NOT be used in pressurized intravenous lines due to the potential for product leaks. Regardless of the lot, prior to administration, tear the overwrap (outer bag) down the side at the slit and remove the inner bag. Inspect the bag for low fill volume and for leaked fluid in the space between the overwrap and inner bag. Check for minute leaks by squeezing the inner bag firmly If any leakage is observed, the bag should be discarded due to the potential risk of contamination. Monitor for leakages from the bag during treatment and stop using if leakage is observed. Potential leakages may not be easily identified without the application of pressure over time. In the affected lots, leaks are more likely to be found in the area shown in Appendix B. Gloves should be worn when handling the bags to avoid exposure to any hazardous medications that may have been added to the bags. Action taken by Health Canada Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Health Canada has directed Baxter Corporation, the market authorization holder for 0.9% Sodium Chloride Injection, USP 500 mL and Lactated Ringer’s Injection, USP 500 mL, to ensure that they inform all impacted healthcare professionals, patients and personnel administering or handling these products. Health Canada is monitoring the company’s implementation of any additional corrective and preventative actions. If additional safety information is identified, Health Canada will take appropriate action and inform Canadians as needed. Report health or safety concerns Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and consumers reporting adverse reactions and medical device incidents. Any case of product-related adverse reactions, including blood infections, or other serious or unexpected adverse reactions in patients receiving 0.9% Sodium Chloride Injection, USP 500 mL and Lactated Ringer’s Injection, USP 500 mL should be reported to Baxter Corporation or to Health Canada. Baxter Corporation 7125 Mississauga Rd Mississauga, ON L5N 0C2 To correct your mailing address or fax number, contact Baxter Corporation at fca_canada@baxter.com You can report any suspected adverse reactions associated with the use of health products to Health Canada by: Calling toll-free at 1-866-234-2345; or Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax. For other health product inquiries related to this communication, contact Health Canada at: Health Product Compliance Directorate, Regulatory Operations and Enforcement Branch E-mail: hpce-cpsal@hc-sc.gc.ca Telephone: 1-800-267-9675 Original signed by Azmina Kanji Manager, Quality Systems Baxter Corporation - Canada Appendix A: Affected Lots Product Name: 0.9% Sodium Chloride Injection, USP Package Size: 500 mL Product Code: JB1323 Market Authorization Holder: Baxter Corporation DIN: 00060208 Lot Number Expiration Date 1 W1I14B0F DEC22 2 W1I15B0 DEC22 3 W1I23B0 DEC22 4 W1I24B0 DEC22 5 W1I30B0 DEC22 6 W1J07B0 JAN23 7 W1J20B0 JAN23 8 W1J22B0 JAN23 9 W1J25B1 JAN23 10 W1J26B0 JAN23 11 W1J27B1 JAN23 12 W1J29B0 JAN23 13 W1K02B0 FEB23 14 W1K03B0 FEB23 15 W1K19B0 FEB23 16 W1K25B0 FEB23 17 W1K25B0F FEB23 18 W1L02B0 MAR23 19 W1L03B0 MAR23 20 W1L09B0 MAR23 21 W1L10B0 MAR23 22 W1L10B0B MAR23 23 W1L11B0 MAR23 24 W1L16B0 MAR23 25 W1L17B0 MAR23 26 W2A13B0 APR23 27 W2A14B0 APR23 28 W2A19B1 APR23 29 W2A20B0 APR23 30 W2A21B0 APR23 31 W2A22B0 APR23 32 W2A26B0 APR23 33 W2A29B0 APR23 34 W1E05B0 AUG22 35 W1E06B0 AUG22 36 W1E11B0 AUG22 37 W1E18B0 AUG22 38 W1E21B0 AUG22 39 W1E27B0 AUG22 40 W1F03B0 SEP22 41 W1F04B0 SEP22 42 W1F11B0 SEP22 43 W1F12B0 SEP22 44 W1F18B0 SEP22 45 W1F22B0 SEP22 46 W1F23B0 SEP22 47 W1F25B0 SEP22 48 W1F28B0 SEP22 49 W1F29B0 SEP22 50 W1F30B0 SEP22 51 W1G14B0 OCT22 52 W1G15B0 OCT22 53 W1G16B0 OCT22 54 W1G16B0B OCT22 55 W1G20B0 OCT22 56 W1G21B0 OCT22 57 W1G29B0 OCT22 58 W1G30B0 OCT22 59 W1H13B0 NOV22 60 W1H19B0 NOV22 61 W1H20B0 NOV22 62 W1H26B0 NOV22 63 W1H27B0 NOV22 64 W1I01B0 DEC22 65 W1I03B0 DEC22 66 W1I09B0 DEC22 67 W1I10B0 DEC22 68 W1I14B0 DEC22 Product Name: Lactated Ringer’s Injection, USP Package Size: 500 mL Product Code: JB2323 Market Authorization Holder: Baxter Corporation DIN: 00061085 Lot Number Expiration Date 1 W1H04B0 NOV22 2 W1I17B0 DEC22 3 W1J28B0 JAN23 4 W1K26B0 FEB23 5 W1L22B0 MAR23 6 W2A27B0 APR23 7 W2A27B0S APR23 8 W1E14B0 AUG22 9 W1F24B0 SEP22 Appendix B: Area or Location of Potential Leakage In the affected lots, leaks are more likely to be found in the area shown below: If any leakage is observed from the bags before or during treatment, stop using the product.

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Brand: 0.9% Sodium Chloride Injection Usp And Lactated Ringer’s Injection Usp.