This page has been archived on the Web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.
Flexor RTPS Guiding Sheath (2015-06-09)
- Starting date:
- June 9, 2015
- Posting date:
- July 8, 2015
- 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-54112
Recalled Product
A.Flexor RTPS Guiding Sheath
Reason
This recall is being initiated by COOK Medical due to reports received indicating the Introducing Dilator Component extends beyond the Introducer sheath further than intended and does not conform to the specifications. Potential adverse events that may occur as a result of the excess dilator length include difficulty in accessing the Hepatic vein, requiring additional manipulation, which could result in vessel injury.
Affected products
A.Flexor RTPS Guiding Sheath
Lot or serial number
- 5770328
- 5770364
- 5805365
Model or catalog number
KCFW-10.0-35-RB-RTPS-100
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES