Warning
1998-22
April 15, 1998
Warning not to use "Modudose 3 ml and 5 ml Vial Sizes 0.9% Sodium Chloride Solution for Respiratory Therapy"; Imported by Canadian Hospital Specialties Ltd.
OTTAWA - Health Canada and Canadian Hospital Specialties Ltd. are warning health care institutions and patients not to use the following products:
- Kendall Product Code # 5251, 3 ml vial, MODUDOSE 0.9% SODIUM CHLORIDE SOLUTION; and
- Kendall Product Code # 5257, 5 ml vial, MODUDOSE 0.9% SODIUM CHLORIDE SOLUTION.
The recall is restricted to all lots of product codes #5251 and #5257. Product codes are clearly visible on shipping case labels and unit cartons.
These products are manufactured by Kendall Healthcare Products in the US and imported by Canadian Hospital Specialties Ltd., Mississauga, Ontario. MODUDOSE 0.9% SODIUM CHLORIDE SOLUTION FOR RESPIRATORY THERAPY is used primarily in hospitals in administering drugs that may be used to treat chest or lung infections and to assist in suctioning fluid from lungs of intubated patients. This product may also be used in clinics or home care settings for similar purposes.
The product is sold in 3 ml and 5 ml vials. In the US, two lots of this product have been found to contain the bacteria Ralstonia pickettii (formerly referred to as Pseudomonas pickettii and Burkholderia pickettii). While there have been no adverse reports in either the US or Canada, Ralstonia pickettii has been associated with respiratory tract infections in those people with lung disease or immunocompromised patients. Further investigation is being conducted by Health Canada's Therapeutic Products Programme.
Health Canada and Canadian Hospital Specialties Ltd. are issuing this warning to advise health care institutions and patients who may be using MODUDOSE Product Codes # 5251 and 5257, 0.9% SODIUM CHLORIDE SOLUTION FOR RESPIRATORY THERAPY, through the Canadian Medical Association, the Canadian Pharmaceutical Association, the Canadian Hospital Association, the Canadian Association of Hospital Pharmacists, the Canadian Healthcare Association, the Canadian Asthma and Allergy Association, and the provincial Ministries of Health.
The Canadian distributor, Canadian Hospital Specialties Ltd., has voluntarily stopped sale of this product in Canada, notified all customers, and requested the return of all unused vials of the product. In the meantime, health care institutions and patients are advised to discontinue use of this product and to use other saline solutions available on the Canadian market. Health care providers or patients requiring additional information should contact David Enns at Canadian Hospital Specialties Ltd., (905) 828-2565.
Media inquiries:
Trish Maynard
Health Canada
Pager: (613) 791-3105
General Inquiries
(613) 957-2991
|
