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Vitesse and Turbo Elite Catheters (2016-10-31)
- Starting date:
- November 2, 2016
- Posting date:
- November 25, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-61204
Affected Products
- A. Vitesse - COS Escimer laser Ablation Catheter
- B. Turbo Elite Catheter RX
Reason
The integrity of the outer sterile packaging may have been compromised.
Affected products
A. Vitesse - COS Escimer laser Ablation Catheter
Lot or serial number
FTT16D07A
Model or catalog number
114-009
Companies
- Manufacturer
-
Spectranetics Corporation
9965 FEDERAL DRIVE
COLORADO SPRINGS
80921
Colorado
UNITED STATES
B. Turbo Elite Catheter RX
Lot or serial number
FBE16E25A
FBF16E12A
FBG16E02A
Model or catalog number
410-154
414-159
417-156
Companies
- Manufacturer
-
Spectranetics Corporation
9965 FEDERAL DRIVE
COLORADO SPRINGS
80921
Colorado
UNITED STATES