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Y Tubing Optistar/Coiled Extension Tubing, Optistar Mr. Injection System and Optistar Le Contrast Delivery System (February 14, 2012)

Starting date:
February 14, 2012
Posting date:
March 19, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71635

Reason

Sterilized packages of product that are unsealed have been identified during extensive investigation. Two units of product were noted to have open seals, thereby compromising the product sterility.

Affected products

Y Tubing Optistar/Coiled Extension Tubing

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

601195, 801106, 801107

Companies

Manufacturer
Not Applicable



Optistar Mr. Injection System

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

801104

Companies

Manufacturer
Not Applicable



Optistar Le Contrast Delivery System

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

801801

Companies

Manufacturer
Not Applicable