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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
- Date modified: