Hospira Sodium Chloride 0.9% Irrigation, USP, 3000 mL Flexible Container (DIN 00037826, Lot 29037JT) - Recall of One Lot - Notice to Hospitals

Starting date:
May 16, 2014
Posting date:
May 17, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-39559

This is a 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

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Sodium Chloride 0.9% Irrigation, USP, 3000mL flexible container, lot 29037JT

May 16, 2014

Dear Chief of Medical Staff and Director of Pharmacy

Please distribute to relevant Departments (Oncology, Pharmacy, Geriatrics, Internal Medicine, Nursing, Paediatrics, Intensive Care Unit, Coronary Care, Emergency Department, Surgery, Anaesthesia, Recovery Room and/or other Departments as required), and other involved professional staff and post this Notice in the relevant areas of your institution.

Subject:  Recall of one lot of Hospira Sodium Chloride 0.9% Irrigation, USP, 3000 mL flexible container (DIN 00037826, Lot 29037JT) due to potential leakage of bags.

Hospira Healthcare Corporation, in consultation with Health Canada, is recalling one lot (Lot 29037JT) of Sodium Chloride 0.9% Irrigation, USP, 3000 mL flexible container due to the potential for leakage of the bags. During visual inspection, Hospira identified primary bag leaks.

Leaking bags of Sodium Chloride 0.9% Irrigation, USP may result in compromised sterility and potential for contamination.

  • One lot of Sodium Chloride 0.9% Irrigation, USP, is being recalled due to the potential for leakage of the bags and possible compromised sterility and contamination.
     
  • Bags of the affected lot (29037JT) should not be used and should be returned to Hospira Healthcare.
     
  • In general, healthcare professionals should inspect the flexible containers of Sodium Chloride 0.9% Irrigation for damage to the container or leakage prior to patient administration. If any damage or leakage is observed, the flexible container should not be used and the incident reported to Hospira Healthcare.

Product impacted by this issue is listed below:

Description - Sodium Chloride 0.9% Irrigation, USP, 3000mL
DIN - 00037826
List Number - 07972259
Lot No. - 29037JT
Expiry Date - May 1, 2015

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 adverse reaction or other serious or unexpected adverse reactions in patients receiving Sodium Chloride 0.9% Irrigation, USP 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
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

 


 

 





 

For more information

The manufacturer advised Health Canada of the risk associated with this health product's quality, and has recalled the impacted products. 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.