Important Information: Additional Recalled Lubricating Jelly Products

Starting date:

February 17, 2011

Posting date:

February 17, 2011

Type of communication:

Information Update

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information, Contamination

Audience:

Healthcare Professionals, General Public

Identification number:

RA-110004880

• Report health or safety concerns
• Media enquiries
• Public enquiries

Following our communication regarding Bowers Medical Ltd. voluntary recall of Triad Group's sterile lubricating jelly, Health Canada is informing Canadians that additional health products have been identified. These products can be found as either a single sterile product or part of a kit. Lubricating Jelly is used to lubricate medical devices, such as catheters, for insertion into body orifices.

The Triad Group, in consultation with Health Canada, has initiated a voluntary recall of all lots of Sterile Lubricating Jelly, with their labelled expiration dating back to 2007, due to the possibility of that the product may not have been sterilized properly, which can cause infection. As of today, Health Canada has not received any reports of adverse reactions related to the use of Triad Group's Lubricating Jelly recalled products.

Health Canada would like to remind Canadians who have concerns about the products listed below to consult with their health care practitioner. Canadians may also wish to talk to their health care practitioner if they or any member of their family are currently using health products that are co-packaged with lubricating jelly to determine if the jelly is manufactured by Triad.  The Triad Group can be contacted directly for information concerning this recall at 1-800-288-1288.

Should any new information be identified, Health Canada will continue to provide an update to Canadians.

Product Recall Information:

The companies identified below, in consultation with Health Canada, have all initiated a voluntary recall of the affected recalled products distributed by them. Health Canada is working with these companies and will monitor the recall of these products from the Canadian market.

PRODUCT	Company	Distribution Level
Kits and packs for the insertion of catheters which contain Triad Sterile Lubricating Jelly	Medline Canada	Shoppers Home Healthcare and Medical Mart Retail Stores in Ontario and Quebec
Cysto-Care Catheter Irrigation, Insertion, Procedure Trays include a sterile pack of Triad Lubricating Jelly	Coloplast Canada Corporation	Shoppers Drug Market, Shoppers Home Health Care, Express Home Health Canada, Ontario Medical Supply Ltd. across Canada
"DeRoyal Sterile Water Soluble Lubricant" as a single product	CAN-med Healthcare, Dismed Inc.	Hospitals in Nova Scotia
Assorted Sterile Catherization Kits & Trays	Cardinal Health Canada	Hospitals nationwide
Urology Procedure Tray including  sterile pack of Triad Lubricating Jelly and Lubricating Jelly as a single product	Omega Medical Canada	Hospitals in Quebec and Ontario, Home Health Care in Quebec. Not available at retail level.

 

Report health or safety concerns

Complaints involving Triad's Lubricating Jelly can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9

Media enquiries

Health Canada
613-957-2983

Public enquiries

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at 613-957-2991, or toll free at
1-866-225-0709.