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