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Important Safety Information on Baxter Infusion Pumps - Notice to Hospitals
- Starting date:
- October 25, 2005
- Posting date:
- October 25, 2005
- Type of communication:
- Notice to Hospitals
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Audience:
- Hospitals
- Identification number:
- RA-170001060
Notice about Health Canada advisories
Notice to Hospitals - Health Canada Issued Important Safety Information on Baxter Infusion Pumps
Posted but not faxed to institutions
October 25, 2005
To: Hospital Chief of Medical Staff
Please distribute to the relevant Departments of Medicine, Intensive Care, Emergency and other involved professional staff and post this Notice in your institution
Subject: FDA seizure of Baxter pumps
Brand names: SYNDEO PCA Syringe Pumps, Colleague Volumetric Infusion Pumps, and Colleague CX Volumetric Infusion Pumps
Manufacturer: Baxter Healthcare Corp.
1 Baxter Parkway, Deerfield 60015 IL USA
On October 13, 2005, Baxter Healthcare Corporation announced that the U.S. Food and Drug Administration (FDA) has seized approximately 6,000 Baxter-owned Colleague® Volumetric Infusion Pumps and approximately 850 SYNDEO® PCA Syringe Pumps currently on hold at two facilities in Illinois. FDA recommended this seizure after their inspections of Baxter allegedly found infractions of US Quality System regulations. No products were seized from healthcare facilities or individual users and the FDA has no plans to do so.
Both the FDA and Baxter have advised owners of these pumps to continue to use them as directed by the Operator's Manual and all field corrective actions previously communicated by Baxter.
This seizure does not currently affect the sale or distribution of Baxter pumps in Canada.
Health Canada is monitoring the corrective actions by Baxter.
Recommendation:
- Owners of Baxter pumps may continue to use them as directed by the Operator's Manual and all field corrective actions previously communicated by Baxter.
Health Canada depends on health care professionals to report adverse incidents related to medical devices. Any serious or unexpected incidents should be reported to Health Canada at the following address:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
For other inquiries, please refer to contact information:
Medical Devices Bureau
E-mail: mdb_enquiries@hc-sc.gc.ca
Telephone: 613-957-4786
Fax: (613) 957-7318
The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.