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0.9% Sodium Chloride Injection USP and 5% Dextrose Injection USP - Recalled Lot Due to the Potential for Leakage of the Parenteral Solution Bag
- Starting date:
- March 4, 2015
- Posting date:
- March 4, 2015
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Important Safety Information
- Identification number:
This is duplicated text of a letter from the Baxter Corporation prepared in collaboration with Health Canada.
Health Care Professionals working in the following settings: Hospitals, Pharmacy, Nursing, Surgery, Emergency departments, Long term care facilities, Clinics, Dentistry, Homecare nursing and other relevant areas.
- Baxter is recalling one (1) lot of 0.9% Sodium Chloride Injection USP, 50 mL and one (1) lot of 5% Dextrose Injection USP, 50 mL due to the potential for leakage of the parenteral solution bag.
- Leakage of a parenteral solution bag may result in delay or interruption of therapy, microbial contamination, and air in the system. If used in IV admixture, there is potential for delivery of a more concentrated drug solution than intended.
- Baxter is advising all users to immediately locate and remove the affected lots from use and return all affected inventory to Baxter Corporation. The affected lots should not be used.
Baxter has initiated a recall of one (1) lot of 0.9% Sodium Chloride Injection USP, 50 mL and one (1) lot of 5% Dextrose Injection USP, 50 mL due to potential leakage of the parenteral solution bag. Leakage of parenteral solution bags may result in patient harm or adverse health consequences including blood stream infection and air embolism.
These lots were distributed in Canada between April 02, 2014 and August 07, 2014.
The products impacted are:
|Product name||DIN||Package format||Lot number||Expiry date|
|0.9% Sodium Chloride Injection USP||00060208||50 mL||P313684||August 31, 2015|
|5% Dextrose Injection USP||00060348||50 mL||P313031||July 31, 2015|
0.9% Sodium Chloride Injection USP is indicated as a source of water and electrolytes and 5% Dextrose Injection USP is indicated as a source of water and calories.
Baxter received complaints for leakage of the parenteral solution bag of both specified lots; but has not received any reports of adverse events. The root cause was determined to be a malfunction of one component of the bag making/sealing equipment. Baxter has resolved the issue and product currently being shipped is not affected.
Who is affected
Information for consumers
Patients who have affected lots in their homes should not use the affected lots and notify their Health Care Professional.
Consumers should contact their Health Care Professional for more information.
Information for health care professionals
The specified solution lots should not be used. Contact Baxter Customer Care to arrange for return and credit of the affected lot numbers at 1-888-719-9955.
Health Care Professionals should also notify affiliated staff administering this product in a homecare setting.
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 is also monitoring the recall and the implementation of necessary corrective and preventive actions.
Report health or safety concerns
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious blood infection or air embolism or other serious or unexpected side effects in patients receiving 0.9% Sodium Chloride Injection USP, 50 mL or 5% Dextrose Injection USP, 50 mL should be reported to Baxter Corporation or Health Canada.
7125 Mississauga Road
Mississauga, ON, L5N 0C2
To report an Adverse Reaction, health professionals and consumers may call toll free:
Phone: 1-800-387-8399 ext 6607
To correct your mailing address or fax number, contact contact Baxter Customer Care at 1-888-719-9955.
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 fax
For other health product inquiries related to this communication, contact Health Canada at:
Health Products and Food Branch Inspectorate
Original signed by
Quality Systems Manager
For more informationThe manufacturer advised Health Canada of the risk associated with this health product, and has recalled the impacted product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.
- Date modified: