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.