This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
BARDEX I.C. 2-WAY FOLEY CATHETERS (2015-12-23)
- Starting date:
- December 23, 2015
- Posting date:
- January 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56744
Affected Products
- BARDEX I.C. 2-WAY FOLEY CATHETERS
Reason
Bard is notifying customers that the instructions for use (IFU) included with the named BARDEX I.C. 2-way Foley catheters and 2-way Council tip Foley catheters distributed by the manufacturer from June 2013 to June 2015 provide the incorrect inflation volume. The inflation volume provided on the catheter's valve cap does state the correct inflation volume.
Affected products
A. BARDEX I.C. 2-WAY FOLEY CATHETERS
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- 0165SI08
- 0165SI10
- 0165SI12
- 0165SI14
- 0165SI16
- 0165SI18
- 0165SI20
- 0165SI22
- 0165SI24
- 0165SI26
- 0165SI28
- 0165SI30
- 0196SI16
- 0196SI18
- 0196SI20
- 0196SI22
Companies
- Manufacturer
-
C.R. Bard, Inc.
8195 INDUSTRIAL BLVD.
COVINGTON
30014
Georgia
UNITED STATES