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Cook's Teflon Coated Products and Wireguides (2017-11-01)
- Starting date:
- November 1, 2017
- Posting date:
- December 14, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65416
Affected products
A. TEFLON COATED AMPLATZ WIREGUIDES
B. Teflon Coated Bentson
C. Teflon Coated Coons Wireguides
D. Teflon Coated Safe-T-J Wireguides
E. Teflon Coated Generic Wireguides
F. Teflon Coated Tefcor Wireguides
G. Teflon Coated Spencer Modified Biliary Wireguides
H. Teflon Coated Newton Wireguides
I. Generic Wireguides
J. Disposable Reuter Tip Deflecting Wireguides
Reason
This correction involves applying an additional label that states "Heparin Coated" to the affected products. Some products are not explicitly labeled that they are heparin coated. This correction is only related to the label, not the products.
Affected products
A. TEFLON COATED AMPLATZ WIREGUIDES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
THSCF-XXX-AES
THSF-XXX-AUS3
THSFNA-AUS-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
B. Teflon Coated Bentson
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
TSFB-XXX
TSFBP-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
C. Teflon Coated Coons Wireguides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
THSF-COONS-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
D. Teflon Coated Safe-T-J Wireguides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
THSCF-ROSEN-XXX
THSF-AES-XXX
TSCF-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
E. Teflon Coated Generic Wireguides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
C-TDOC-XXX
C-THSCF-XXX
THSF-ASG-XXX
THSF-XXX
TSF-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
F. Teflon Coated Tefcor Wireguides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
TMT-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
G. Teflon Coated Spencer Modified Biliary Wireguides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
TCMTNA-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
H. Teflon Coated Newton Wireguides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
TSCFNA-XXX
TSCFNB-XXX
TSFNA-XXX
TSFNB-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
I. Generic Wireguides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
C-DOC-XXX
C-SF-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
J. Disposable Reuter Tip Deflecting Wireguides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DTDW-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES