Infiniti Bracket (sold as part of CIVCO brand Biopsy Starter Kits and Biopsy Bracket) (2018-02-26)

Starting date:
February 26, 2018
Posting date:
March 2, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66082

Affected products

Infiniti Bracket (sold as part of CIVCO brand Biopsy Starter Kits and Biopsy Bracket)

Reason

CIVCO has recently discovered a quality issue with Infiniti bracket. The affected brackets were included in the kits identified and manufactured between 11/2009 through 12/2017.

Description of Problem: If the length of the mount may be longer than specified, it can allow the needle guide insert to puncture the cover which is applied between the mount and needle guide assembly. This does not prevent the assembly from functioning as intended to keep the biopsy needle in the ultrasound scanning plane.

Affected products

Infiniti Bracket (sold as part of CIVCO brand Biopsy Starter Kits and Biopsy Bracket)

Lot or serial number

M220960
M388690
M419650
M427370
 

Model or catalog number

698-009

Companies
Manufacturer
Civco Medical Instruments Co. Inc.
102 First Street South
Kalona
52247
UNITED STATES