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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