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Archived – Risks Associated with Soft Tissues from Cryolife Inc. Used for Transplantation
- Starting date:
- August 27, 2002
- Posting date:
- August 27, 2002
- Type of communication:
- Notice to Hospitals
- Subcategory:
- Biologic/vaccine
- Source of recall:
- Health Canada
- Issue:
- New safety information
- Audience:
- Hospitals
- Identification number:
- RA-17000290
This is duplicated text of a letter from CryoLife, Inc.
Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
Notice to Hospitals from the Biologics and Genetic Therapies Directorate (BGTD)
August 27, 2002
Health Canada has become aware of risk of fungal and bacterial contamination of soft tissues for implantation processed and sold by CryoLife Inc.. This risk involves products such as cartilage, tendons and fascia. As a result a letter was sent to CryoLife Inc. to stop the sale and recall all products it sells in Canada with the exception of aortic and mitral valves, leaflets and patches and Bioglue surgical adhesive.
If a bacterial or fungal infection were to occur following a transplant, the signs and symptoms would usually occur within days or weeks after implantation. It is therefore unlikely that patients who have received infected tissue would be at risk beyond this critical period.
The Food and Drug Administration (FDA) in the United States has also initiated a recall due to infections having been reported with these implants and the occurrence of one confirmed death following knee allograft surgery. No cases of death or infection have been reported in Canada.
Should your facility have any of the affected tissue products supplied by CryoLife to you since October 3rd, 2001, please do not use the tissue but immediately contact CryoLife regarding its disposal at:
CryoLife, Inc.,
1655 Roberts Boulevard, NW,
Kennesaw, Georgia, 30144 USA;
Phone (770) 419-3355 or (800) 438-8285
Fax (770) 590-3742.
Health Canada asks that you share these recommendations with your staff or membership and encourage their implementation in the interest of patient safety.
If you have any concerns or reports about other CryoLife products please contact the Biologics and Genetic Therapies Directorate at the address below, or telephone 613 954-5706, fax 613 957-6302.
Biologics and Genetic Therapies Directorate
Building No. 6
Tunney's Pasture, A.L. 0603D
Ottawa, Ontario
K1A 0L2