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Health product recall

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