Bard SILASTIC® Foley Catheter
Brand(s)
Last updated
Summary
Product
Bard SILASTIC® Foley Catheter
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33416 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33420 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33620 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33622 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33418 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33422 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33616 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33614 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33618 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33424 |
| SILASTIC® Foley Catheter | More than 10 numbers, contact manufacturer. | 33624 |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
C.R. Bard, Inc.
8195 Industrial Blvd., Covington, Georgia, United States, 30014
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82037
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