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Archive - Health Canada warns consumers not to use certain lots of Comfort Shield Personal Cleansing Perineal Care Washcloths due to potential health risks

Starting date:
June 28, 2006
Posting date:
June 28, 2006
Type of communication:
Advisory
Subcategory:
Medical Device
Source of recall:
Health Canada
Identification number:
RA-110001323

Health Canada is warning consumers not to use certain lots of Comfort Shield Personal Cleansing Perineal Care Washcloths due to bacterial contamination that could cause serious adverse health effects in patients who are hospitalized or receiving long-term care, particularly in those with a weakened immune system or chronic lung disease.

A recall of the product has been initiated by the distributor, Source Medical Corporation. The cloths are sold to hospitals and long-term care facilities and are also for sale on the Internet. The affected lots recalled are: product code: 7403, lot numbers: 1301, 1312, 1651, 1677, 1457 and product code: 7408, lot number: 1848. The lot number can be found on the label.

Comfort Shield Personal Cleansing Perineal Care Washcloths, manufactured by Sage Products Inc., are premoistened washcloths intended to help treat and prevent skin problems due to urinary or fecal incontinence.

The washcloths from the affected lots are contaminated with the Burkholderia cepacia bacteria.

Burkholderia cepacia can cause serious infections, including pneumonia and blood infection, in patients with weakened immune systems or chronic lung diseases. The effects can range, from no symptoms to serious respiratory infection, especially in patients with cystic fibrosis. In general, this bacteria poses little medical risk to healthy people.

While no adverse reactions associated with this product have been officially reported to Health Canada, the distributor is following up on possible adverse reactions that may have occurred.

Consumers who have used the product and have concerns about their health should contact their physician or health care practitioner.

Consumers should discontinue use of the affected lots and are advised to dispose of the contaminated product with the guidance of their local authorities.

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.

The U.S. Food and Drug Administration issued an advisory about this recall.

To report a suspected adverse reaction with these or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 866-234-2345
Facsimile: 866-678-6789

CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
Email: cadrmp@hc-sc.gc.ca

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709