Health professional risk communication

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

Last updated

Summary

Product
0.9% Sodium Chloride Injection, USP and Lactated Ringer’s Injection, USP
Issue
Health products - Product quality
Health products - Product safety
What to do

See Key Messages below

Audience
Health professionals

Affected products

Product Name

Package Size

Product Code

Market Authorization Holder

DIN

Lot Numbers/ Expiration Dates

0.9% Sodium Chloride Injection, USP

500 mL

JB1323

Baxter Corporation

00060208

See Appendix A

Lactated Ringer’s Injection, USP

500 mL

JB2323

Baxter Corporation

00061085

See Appendix A

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.

 

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.

Additional information

Details
Original published date: 2022-03-09
Alert / recall type
Health professional risk communication
Category
Health product - Drugs
Published by
Health Canada
Audience
Health professionals
Identification number
RA-63973