Health product recall

StartVPS Clear Bite (4-pack) (impression material) (2018-09-23)

Starting date:
September 23, 2018
Posting date:
October 19, 2018
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-67946

Affected products

StartVPS Clear Bite (4-pack) (impression material)

Reason

Outer carton incorrectly identifies product as Ultra Heavy impression material, part number 80062-01. Actual material, as identified on immediate label, is Clear Bite, part number 80015-01. Labeling error was detected by Danville Materials on 09/21/2018 after material was returned from customer identified as "wrong part shipped".

Affected products

StartVPS Clear Bite (4-pack) (impression material)

Lot or serial number

L0J8Q

Model or catalog number

80015-01

Companies
Manufacturer
Danville Materials
2875 Loker Avenue East
Carlsbad
92010
California
UNITED STATES