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MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK (2016-05-11)
- Starting date:
- May 11, 2016
- Posting date:
- May 30, 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-58612
Affected products
A. MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK
Reason
It was discovered during post-quarantine packaging on February 16, 2016 that the IFU for the StatLock Sheath Stabilization device for Percutaneous Sheath Introducers (incorrect IFU) was erroneously packaged with the MEGA and SENSATION PLUS IAB Catheter kits, instead of the IFU for the StatLock Catheter Stabilization device for IAB Catheters (correct IFU).
Affected products
A. MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
0684-00-0296-01
Companies
- Manufacturer
-
Datascope Corp.,
15 Law Drive,
Fairfield
07004
New Jersey
UNITED STATES