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Health
Canada Warns Consumers of Potential Health Risks
of Comfort Shield Personal Cleansing Perineal
Care Washcloths
June
29, 2006
Health Canada
is warning consumers not to use certain lots of
Comfort Shield Personal Cleansing Perineal Care
Washcloths because of bacterial contamination
that could cause serious adverse health effects
in patients who are hospitalized or receiving
long-term care, especially 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 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.
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
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