Gemstar Pump Sets - Recall - For Health Professionals

Starting date:

August 9, 2010

Posting date:

September 8, 2010

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002278

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 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:

Hospira Healthcare Corporation
Complaint and Safety Department
1111 Dr Frederik-Philips, Suite 600
Saint-Laurent (Québec), H4M 2X6
To Report Adverse Reaction, Consumers and Health Professionals may call toll free:
Tel: 866-488-6088 Option 6
Fax: 877-906-0208
ProductcomplaintsCA@hospira.com

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

Sincerely,

original signed by

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