Print | Need Larger Text? | Share

Gemstar Pump Sets - Recall - For Health Professionals

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

(PDF Version - 120 K)

Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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

Health Canada Endorsed Important Safety Information on Gemstar Pump Sets

August 9, 2010

Subject: Recall of Gemstar Pump Sets due to under delivery

Dear Health Care Professional,

Hospira is conducting a voluntary recall on specific lots of Gemstar pump sets (Table 1). The affected lots were distributed in Canada between November 2008 and June 2009.  No other lots are impacted by this recall and replacement product is available.

Hospira is taking this voluntary action due to reports that under delivery occurred during clinical use.  Our investigation determined that under delivery can occur under low rate settings (less than 10 mL/hour). We have not received any reports of delay in critical therapy or adverse events resulting from this issue.  This recall is being conducted as a precautionary measure.  The root cause has been identified and preventive actions have been implemented.

This recall is being conducted with the knowledge of Health Canada.

Please check your inventory immediately, quarantine any affected product, and contact Hospira at 1-866-488-6088, option 4 or by email at: mail-ClinSupport@hospira.com.

Please inform healthcare professionals in your organization of this recall.  If you have distributed the product further, notify your accounts that may have received the product identified above of this recall.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any case of serious delay in critical therapy or other serious or unexpected adverse incidents for medical devices in patients using Gemstar Pump Sets should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:

Sincerely,

original signed by

Beryl Chan
Regional Director, Quality and Regulatory Affairs
Hospira Healthcare Corporation