This page has been archived on the Web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.
Cook Inc. Performer Introducers (2017-02-03)
- Starting date:
- February 3, 2017
- Posting date:
- March 16, 2017
- 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-62630
Affected Products
A. Micropuncture Check Flo Performer Introducer
B. Balkin Up and Over Contralateral Introducers
C. Flexor Check-Flo Performer Introducer
D. Triforce Peripheral Crossing Set
E. Check-Flo Hemostasis Assembly
Reason
Increase in reports of blood loss associated with devices using the hemostatic blue valve design.
Affected products
A. Micropuncture Check Flo Performer Introducer
Lot or serial number
5335434
Model or catalog number
RCFN-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
B. Balkin Up and Over Contralateral Introducers
Lot or serial number
5040369
5364287
5379911
Model or catalog number
RCFW-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
C. Flexor Check-Flo Performer Introducer
Lot or serial number
4667249X
4667286X
4667292X
5102703
5102709
5102709X
5102711
5102713X
5102715X
5102738
5102740
5102740X
5520552
5533811
5580025
5580027
5580029
5580031
5580033
Model or catalog number
RCFW-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
D. Triforce Peripheral Crossing Set
Lot or serial number
5129805
5248809
5459187
5576569
5628927
5720805
5733184
5768551
5785296
5785302
5832319
5849197
5867734
5889168
6025630
Model or catalog number
KCXS-5.0-35-100-RB-0/DAV-HC
KCXS-5.0-35-100-RB-MPB/0-HC
KCXS-5.0-35-100-RB-MPB/DAV-HC
KCXS-5.0-35-65-RB-0/0-HC
KCXS-5.0-35-65-RB-0/DAV-HC
KCXS-5.0-35-65-RB-MPB/DAV-HC
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
E. Check-Flo Hemostasis Assembly
Lot or serial number
5971838
6072479
Model or catalog number
CFM-200
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES