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Cook Inc. catheters, catheter sets and accessories (2016-04-19)
- Starting date:
- April 19, 2016
- Posting date:
- April 27, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58102
Affected Products
- A. NEFF D'AGOSTINO PERCUTANEOUS ACCESS SET
- B. LIVER ACCESS AND BIOPSY NEEDLE SET
- C. KUMPE ACCESS CATHETER
- D. SELECTIVE SALPINGOGRAPHY CATHETER WITH BEACON TIP
- E. WHITE LUMAX GUIDING COAXIAL CATHETER
- F. BEACON TIP WHITE VESSEL SIZING CATHETER
- G. BEACON TIP TORCON NB ADVANTAGE CATHETER
- H. BEACON TIP ROYAL FLUSH PLUS HIGH-FLOW CATHETER
- I. SHUTTLE SELECT SLIP-CATH AND SLIP-CATH BEACON TIP CATHETER
- J. BEACON TIP VESSEL SIZING CATHETER
- K. BEACON TIP CENTIMETER SIZING CATHETER
- L. HASKAL TRANSJUGULAR INTRAHEPATIC PORTAL ACCESS SET
- M. FLUOROSET RADIOGRAPHIC TUBAL ASSESSMENT SET
- N. APRIMA ACCESS NONVASCULAR INTRODUCER SET
- O. TRANSLUMINAL BILIARY BIOPSY FORCEPS SET
- P. BEACON TIP TORCON NB ADVANTAGE CATHETER
Reason
Cook Medical has identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Their preliminary investigation into this matter has identified that environmental conditions, such as storage temperature, humidity, and the use of vaporized hydrogen peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. There may also be other undetermined contributors to this issue. Investigation is ongoing.
Potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Affected products
A. NEFF D'AGOSTINO PERCUTANEOUS ACCESS SET
Lot or serial number
All lots.
Model or catalog number
NPAS-100-D'AGOSTINO-B-050393
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
B. LIVER ACCESS AND BIOPSY NEEDLE SET
Lot or serial number
All lots.
Model or catalog number
LABS
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
C. KUMPE ACCESS CATHETER
Lot or serial number
All lots.
Model or catalog number
023565-BT
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
D. SELECTIVE SALPINGOGRAPHY CATHETER WITH BEACON TIP
Lot or serial number
All lots.
Model or catalog number
J-SSG-504000
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
E. WHITE LUMAX GUIDING COAXIAL CATHETER
Lot or serial number
All lots.
Model or catalog number
LMGRF-7.0C-80-MPA-PULM
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
F. BEACON TIP WHITE VESSEL SIZING CATHETER
Lot or serial number
All lots.
Model or catalog number
NR5.0-35-100-P-10S-PIG-WSC
NR5.0-35-65-P-6S-VCF-WSC
NR5.0-35-70-P-10S-0-WSC
NR5.0-35-70-P-10S-CFP-WSC
NR5.0-35-70-P-10S-PIG-WSC
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
G. BEACON TIP TORCON NB ADVANTAGE CATHETER
Lot or serial number
All lots.
Model or catalog number
HNBR6.0-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
H. BEACON TIP ROYAL FLUSH PLUS HIGH-FLOW CATHETER
Lot or serial number
All lots.
Model or catalog number
HNR5.0-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
I. SHUTTLE SELECT SLIP-CATH AND SLIP-CATH BEACON TIP CATHETER
Lot or serial number
All lots.
Model or catalog number
SCBR5.0-XXX
SCBR5.5-XXX
SCBR6.5-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
J. BEACON TIP VESSEL SIZING CATHETER
Lot or serial number
All lots.
Model or catalog number
NR5.0-35-70-P-10S-PIG-CAVA
NR5.0-35-70-P-10S-VCF-CAVA
NR5.0-35-90-P-10S-PIG-CAVA
NR5.0-35-90-P-10S-VCF-CAVA
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
K. BEACON TIP CENTIMETER SIZING CATHETER
Lot or serial number
All lots.
Model or catalog number
NR5.0-35-100-P-10S-0-CSC-20
NR5.0-35-100-P-10S-PIG-CSC-20
NR5.0-35-100-P-10S-VCF-CSC-20
NR5.0-35-70-P-10S-0-CSC-20
NR5.0-35-70-P-10S-PIG-CSC-20
NR5.0-35-70-P-10S-VCF-CSC-20
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
L. HASKAL TRANSJUGULAR INTRAHEPATIC PORTAL ACCESS SET
Lot or serial number
All lots.
Model or catalog number
HTPS-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
M. FLUOROSET RADIOGRAPHIC TUBAL ASSESSMENT SET
Lot or serial number
All lots.
Model or catalog number
J-RTAS-100
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
N. APRIMA ACCESS NONVASCULAR INTRODUCER SET
Lot or serial number
All lots.
Model or catalog number
NPAS-100-HC-NT-U-SST
NPAS-100-HC-U-SST
NPAS-101-HC-NT-U-SST
NPAS-101-HC-U-SST
NPAS-104-HC-NT-JWG-U-SST
NPAS-104-HC-NT-U-SST
NPAS-104-HC-U-SST
NPAS-105-HC-NT-U-SST
NPAS-108-HC-NT-U-SST
NPAS-120-HC-NT-U-SST
NSSW-4.0-18-NPAS-100-HC-SST
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
O. TRANSLUMINAL BILIARY BIOPSY FORCEPS SET
Lot or serial number
All lots.
Model or catalog number
BBFS-100
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
P. BEACON TIP TORCON NB ADVANTAGE CATHETER
Lot or serial number
All lots.
Model or catalog number
HNBR5.0-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES