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BARD DENALI IVC FILTER, FEMORAL (2016-02-16)
- Starting date:
- February 16, 2016
- Posting date:
- February 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-57212
Affected Products
BARD DENALI IVC FILTER, FEMORAL
Reason
Bard Peripheral Vascular is initiating a recall of specific product code/lot number combinations of Denali IVC filters following notice from the supplier of the stopcock assembly that these lots are at risk of having cracks in the stopcock body. This issue is isolated to the stopcock itself which is a component of the delivery system and remains external to the body throughout the surgical procedure.
Affected products
BARD DENALI IVC FILTER, FEMORAL
Lot or serial number
GFZJ0277
GFZJ0425
Model or catalog number
DL900F
Companies
- Manufacturer
-
Bard Peripheral Vascular Inc.
1625 West 3rd Street
Tempe
55441
UNITED STATES