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NC Sprinter Rx Balloon Catheter (2013-09-16)
- Starting date:
- September 16, 2013
- Posting date:
- October 16, 2013
- 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-36229
Recalled Products
NC Sprinter Rx Balloon Catheter
Reason
Medtronic initiated a medical device recall of the NC sprinter Rx balloon dilatation catheter, Model NCSP22512X. Medtronic has identified a labeling issue relating to lot number 207002011 in which the compliance chart contained inside the package incorrectly references a 2.5 mm balloon diameter instead of the correct 2.25 mm diameter. As a result, Medtronic is requesting the return of the affected lot of NC Sprinter Rx balloon dilatation catheters.
Affected products
NC Sprinter Rx Balloon Catheter
Lot or serial number
- 207002011
Model or catalog number
- NCSP22512X
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES