Archived – Notice to Hospitals – Comfort Shield Incontinence Care Washcloths

Starting date:

July 7, 2006

Posting date:

July 11, 2006

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001340

This is duplicated text of a letter from Source Medical Corporation.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Notice to Hospitals – Health Canada Endorsed Important Safety Information on Specific Lots of Comfort Shield Incontinence Care Washcloths

July 7, 2006

If you have already responded to previous notices please disregard this communication.

To: Hospital Chief of Medical Staff, Nursing Homes, Long Term Care Centres, Health Clinics and Medical Supply Stores

Please distribute to relevant Departments: Intensive Care, Nursing, Pharmacy, Paediatrics, Geriatrics, Internal Medicine, Purchasing, and/or other Departments as required and other involved professional staff and post this Notice in your institution.

Subject: Urgent: Consolidated Notice regarding Potential Bacterial Contamination of Specific Lots of Comfort Shield Incontinence Care Washcloths

Sage Products Inc. has initiated a Class I recall of the following specific lots of Comfort Shield 3-Pack and 8-Pack Incontinence Care Products due to contamination with Burkholderia cepacia.

Burkholderia cepacia can cause serious infections including pneumonia and sepsis in immunocompromised persons, in cystic fibrosis (CF) patients, in hospitalized patients in general as well as certain other patient groups.

No other lots of Comfort Shield Perineal Care Washcloths are affected by this recall.

Although no adverse reactions associated with the above-referenced lots have been officially reported, Sage Products Inc. is following up on possible adverse reactions that may have occurred.

Customers who have affected products should stop distribution and usage and notify Sage Products' Canadian distributor, Source Medical Corporation to coordinate product return and replacement.

Patients who may have affected product in their home should be advised to dispose of the contaminated product with the guidance of their local authorities.

To arrange for product return and replacement, contact Source Medical Corporation, Customer Service at 1-888-291-5033. Return affected product only, to Source Medical Corporation as instructed by Customer Service.

Any questions from health care professionals may be directed to Sage Products Inc. via Source Medical Corporation at 1-888-871-5945.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of off-odour of product, serious skin rash or other serious or unexpected adverse reactions in patients receiving Comfort Shield Incontinence Care Products should be reported to Source Medical or to Health Canada at the following addresses:

Source Medical Corporation
60 International Blvd.
Toronto, Ontario
M9W 6J2
Tel: 1-888-871-5945

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Health Canada
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866-234-2345
Fax: 866-678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Drug Compliance Verification & Investigation Unit (DCVIU)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Tel: 613-941-3967
Fax: 613-952-9805

Sincerely,

original signed by
Don Cere,
V.P. Marketing and Business Development