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Health product recall

BEACON TIP CATHETERS (2015-07-07)

Starting date:
July 7, 2015
Posting date:
July 29, 2015
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-54440

Affected Products

A. ROYAL FLUSH PLUS NYLON CATHETER WITH BEACON TIP

B.SLIP-CATH ANGIOGRAPHIC NYLON CATHETER - BEACON TIP

C.BEACON TIP TORCON NB ADVANTAGE CATHETER

Reason

Catheter tip splits and/or separation. Potential adverse events that may occur as a result of catheter tip splitting and or separation may include; loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs.

Affected products

A. ROYAL FLUSH PLUS NYLON CATHETER WITH BEACON TIP

Lot or serial number

>10, see importer

Model or catalog number

HNR4.0-XXX

Companies
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES

B.SLIP-CATH ANGIOGRAPHIC NYLON CATHETER - BEACON TIP

Lot or serial number

>10, see importer

Model or catalog number

SCBR5.0-XXX

Companies
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES

C.BEACON TIP TORCON NB ADVANTAGE CATHETER
 

Lot or serial number

 >10, see importer

Model or catalog number

HNBR5.0-XXX

Companies
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES