This page has been archived on the Web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 CHECK-FLO INTRODUCER (2017-09-08)
- Starting date:
- September 8, 2017
- Posting date:
- October 6, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-64762
Affected products
FLEXOR CHECK-FLO INTRODUCER
Reason
This recall is being initiated for the specific lot number 6173030 due to incorrect packaging. Cook medical has received one report of packages labeled as 5.0fr actually containing 6.0fr devices. The event is not likely to lead to an adverse patient or user outcome.
Affected products
FLEXOR CHECK-FLO INTRODUCER
Lot or serial number
6173030
Model or catalog number
KFCW-5.0-35-70-RB-HFANL0-HC-01
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES