Hospira Flexible Intravenous Containers - Potential for Leakage in Certain Lots (1000 mL Intravenous Bags - Sodium Chloride 0.9% Injection USP and Dextrose 5% Injection USP) - For Health Professionals

Starting date:

January 13, 2014

Posting date:

January 14, 2014

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-37569

This is duplicated text of a letter from Hospira Healthcare Corporation. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information Regarding Certain Lots of Hospira Flexible Intravenous Containers (1000 mL Intravenous Bags- Sodium Chloride 0.9% Injection USP and Dextrose 5% Injection USP)

January 13, 2014

Dear Healthcare Professional,

Subject: Potential for Leakage in Certain Lots of Hospira Flexible Intravenous Containers (1000 mL Intravenous Bags- Sodium Chloride 0.9% Injection USP and Dextrose 5% Injection USP)

Hospira Healthcare Corporation, in consultation with Health Canada, is issuing this Important Safety Information Letter to alert Healthcare Professionals of the potential for leakage in 1000 mL flexible containers (intravenous bags) for certain intravenous solutions. During inspection of a manufactured product lot (which was not released onto the Canadian market), Hospira identified leakage due to a puncture through the overwrap and primary container. The root cause is attributed to a defect in a conveyor belt and corrective actions have since been implemented to prevent reoccurrence.  Several product lots are potentially impacted by this issue (refer to the Table below for product lot information). 

Leaking intravenous bags may result in compromised sterility and potential for contamination; exposure of the Healthcare Professional or patient to a hazardous drug that has been added to the intravenous solution; a more concentrated solution than intended; or inadequate or inconsistent medication dosing. 

• Healthcare Professionals should inspect the flexible containers (intravenous bags) of the affected product lots listed below, for damage to the container or leakage prior to patient administration. Refer to the "Assessing for Leaks" section of this letter.
• If any damage or leakage is observed, the flexible container (intravenous bag) should not be used and the incident reported to Hospira Healthcare.

Assessing for Leaks:

1. For flexible containers which have an overwrap, leaked fluid may be visible in the space between the overwrap and container.  If leakage is detected, this should be reported to Hospira Healthcare.
2. Per the instructions on the overwrap container, the user is instructed to visually inspect the overwrap for tears and holes, discard the unit if overwrap is damaged and use the unit promptly once the overwrap is opened.  After removing the overwrap, check for any leaks by squeezing firmly. Additionally, the instructions on the primary container indicate "If leaks are found, discard solution as sterility may be impaired." In either case, if damage to an overwrap or a leaking container is detected, do not use the product and report this to Hospira Healthcare.
3. If the shipper (case) is wet do not use the units. Report the incident to Hospira Healthcare.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse reactions in patients receiving intravenous solutions should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:

Hospira Healthcare Corporation

1111 Dr.-Frederik-Philips, Suite 600

Saint-Laurent (Québec) H4M 2X6

To report an Adverse Reaction, consumers and health professionals may call toll free :

Tel: 1-866-488-6088 Option 6

Fax: 1-877-906-0208
ProductcomplaintsCA@hospira.com

To correct your mailing address or fax number, contact: Hospira Healthcare Corporation. 

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, please contact Health Canada at:

Health and Product and Food Branch Inspectorate (HPFBI)

E-mail: DCVIU_UVCEM@hc-sc.gc.ca

Telephone: 1-800-267-9675

Fax: 1-613-946-5636

Sincerely,

original signed by

Rania Al-Ammar

Regional Director, Commercial Quality

Hospira Healthcare Corporation