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Quick-Cross and QuickCat Catheters (2016-03-31)
- Starting date:
- March 31, 2016
- Posting date:
- April 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58052
Affected Products
A. QUICK-CROSS SUPPORT CATHETER
B. QUICK-CROSS EXTREME SUPPORT CATHETER
C. QUICK-CROSS SELECT SUPPORT CATHETER
D. QUICKCAT EXTRACTION CATHETER
Reason
All shipments since July 2014 containing affected products are suspect of not having instructions for use (IFU) with the product package.
Affected products
A. QUICK-CROSS SUPPORT CATHETER
Lot or serial number
FQL15L09A
FQN15L25A
FQP15M01A
FQQ15M03A
FQR15L30B
FQV15M03A
Model or catalog number
518-033
518-035
518-036
518-037
518-038
518-065
Companies
- Manufacturer
-
Spectranetics Corporation
9965 FEDERAL DRIVE
COLORADO SPRINGS
80921
Colorado
UNITED STATES
B. QUICK-CROSS EXTREME SUPPORT CATHETER
Lot or serial number
FAB15F04A
Model or catalog number
518-076
Companies
- Manufacturer
-
Spectranetics Corporation
9965 FEDERAL DRIVE
COLORADO SPRINGS
80921
Colorado
UNITED STATES
C. QUICK-CROSS SELECT SUPPORT CATHETER
Lot or serial number
FGT15M10A
FGU15K19A
FGV15M08A
FGW15M21A
FSD15H27A
FSH15G29A
FSZ15G30A
Model or catalog number
518-079
518-083
518-087
518-089
518-091
518-093
Companies
- Manufacturer
-
Spectranetics Corporation
9965 FEDERAL DRIVE
COLORADO SPRINGS
80921
Colorado
UNITED STATES
D. QUICKCAT EXTRACTION CATHETER
Lot or serial number
FQT15M09A
FQT16A19A
Model or catalog number
60090-01
Companies
- Manufacturer
-
Spectranetics Corporation
9965 FEDERAL DRIVE
COLORADO SPRINGS
80921
Colorado
UNITED STATES