This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Automatically Change Over Valve for Gas Bottles (CO2) UGV 1 (2014-05-09)
- Starting date:
- May 9, 2014
- Posting date:
- July 25, 2014
- 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-40697
Recalled Products
Automatically Change Over Valve for Gas Bottles (CO2) UGV 1
Reason
During a Health Canada inspection conducted from April 7-16, 2014, the inspector determined the 830202 Automatically Change Over Valve for Gas Bottles (CO2) UGV1 device to be a Class II device in comparison to the original classification of Class I. The product was placed on stop sale and will be recalled and discontinued. Since the commencement of the distribution of the subject device, there has been, neither complaints nor adverse events reported.
Affected products
Automatically Change Over Valve for Gas Bottles (CO2) UGV 1
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
830202
Companies
- Manufacturer
-
Micon Medizintechnik GmbH
Carl-Zeiss-Str. 3
Quickborn
25451
GERMANY