CanadaThe C.R. Bard SILASTIC® Foley Catheter (model/catalogue numbers 33416, 33420, 33620, 33622, 33418, 33422, 33616, 33614, 33618, 33424 and 33624) is affected; contact the manufacturer to confirm lot or serial numbers. It was recalled after complaints and an internal inspection found stains on the catheter surface caused by an increased amount of a raw material that may be harmful if present in increased amounts. Contact the manufacturer if you require additional information.
What's being recalled
Companies: C.R. Bard, Inc., 8195 Industrial Blvd., Covington, Georgia, United States, 30014.
How to identify it
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33416
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33420
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33620
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33622
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33418
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33422
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33616
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33614
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33618
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33424
Affected products: SILASTIC® Foley Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 33624
The hazard
BD has received complaints, and confirmed through internal inspection that stains are present on the surface of the affected SILASTIC® catheters. The cause of the stains was determined to be an increased amount of a raw material used in the manufacturing process. This raw material may be harmful if present in increased amounts on the surface of the catheter.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)