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Health product recall

INNOVA Washer-Disinfectors (2017-10-12)

Starting date:
October 12, 2017
Posting date:
November 30, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Hospitals, General Public, Healthcare Professionals
Identification number:
RA-65268

Affected products

A. INNOVA 700 WASHER-DISINFECTORS

B. INNOVA M4/1080* WASHER-DISINFECTORS

C. INNOVA E3

D. INNOVA M3 WASHER-DISINFECTORS

E. INNOVA M5 WASHER-DISINFECTORS

F. INNOVA E2 WASHER-DISINFECTORS

G. INNOVA E3 WASHER-DISINFECTORS

H. INNOVA E4 WASHER-DISINFECTORS

I. INNOVA M3 WASHER-DISINFECTORS

J. INNOVA E4 CMS WASHER-DISINFECTORS

K. INNOVA E5 CMS WASHER-DISINFECTORS

Reason

This recall has been initiated by the manufacturer for their INNOVA units in order to send updated operator's manuals to the end users. There is no safety issue related to this recall and the units can continue to be used.

Affected products

A. INNOVA 700 WASHER-DISINFECTORS

 

Lot or serial number

7514407

Model or catalog number

50000.1

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



B. INNOVA M4/1080* WASHER-DISINFECTORS

 

Lot or serial number

4871098

5220999

5490700

5800301

Model or catalog number

50200.01

50200.02

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



C. INNOVA E3

 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

50600.00

50600.02 MULTI

50600.10

E3-WD***

E3-WD-MF***

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



D. INNOVA M3 WASHER-DISINFECTORS

 

Lot or serial number

73174029

76083071

Model or catalog number

50500.03S

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



E. INNOVA M5 WASHER-DISINFECTORS

 

Lot or serial number

2188020

Model or catalog number

50300.02

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



F. INNOVA E2 WASHER-DISINFECTORS

 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

E2-WD

E2-WD**

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



G. INNOVA E3 WASHER-DISINFECTORS

 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

50600.02MULTI***

50600.10

50600.10***

E3-WD

E3-WD-R

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



H. INNOVA E4 WASHER-DISINFECTORS

 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

E4-WD

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



I. INNOVA M3 WASHER-DISINFECTORS

 

Lot or serial number

65482001

Model or catalog number

50900.22

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



J. INNOVA E4 CMS WASHER-DISINFECTORS

 

Lot or serial number

59742001

59742002

59742003

59742004

60361001

60361002

60361003

70892001

73447001

73447002

Model or catalog number

E4-CMS

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY



K. INNOVA E5 CMS WASHER-DISINFECTORS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

E5-CMS

E5CMS-DH

ESCMS-DC-EFF

Companies
Manufacturer

BHT HYGIENETECHNIK GMBH

MESSERSCHMITTSTRASSE 11

GERSTHOFEN

86368

GERMANY