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Health product recall

Chummie Bedwetting Alarms (2015-09-29)

Starting date:
September 29, 2015
Posting date:
October 14, 2015
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-55364

Affected Products

  1. Chummie Premium Bedwetting Alarm
  2. Chummie Elite Bedwetting Alarm
  3. Chummie Pro Bed-side Bedwetting Alarm

Reason

Product is lacking an active medical device licence (MDL).

Affected products

A. Chummie Premium Bedwetting Alarm

Lot or serial number
  • L1084M
Model or catalog number
  • TC300B
  • TC300G
  • TC300P
Companies
Manufacturer
THEOS MEDICAL SYSTEMS
2954 SCOTT BLVD
SANTA CLARA
95054
California
UNITED STATES

B. Chummie Elite Bedwetting Alarm

Lot or serial number
  • L1084M
Model or catalog number
  • TCE25B
  • TCE25G
  • TCE25O
  • TCE25P
Companies
Manufacturer
THEOS MEDICAL SYSTEMS
2954 SCOTT BLVD
SANTA CLARA
95054
California
UNITED STATES

C. Chummie Pro Bed-side Bedwetting Alarm

Lot or serial number
  • L1084M
Model or catalog number
  • TC310B
  • TC310P
Companies
Manufacturer
THEOS MEDICAL SYSTEMS
2954 SCOTT BLVD
SANTA CLARA
95054
California
UNITED STATES

Date modified: