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Health product recall

OxyTOTE Style Valve Integrated Pressure Regulators (2015-01-31)

Starting date:
January 31, 2015
Posting date:
February 2, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43563

Recalled Products   

OxyTOTE Style Valve Integrated Pressure Regulators 

Reason

Western decided to initiate this recall based on reports of ignition events involving OxyTOTE valve integrated pressure regulators (VIPRs) and the subsequent investigations into those events. Based on the investigations, Western has become aware of the possibility of ignition and rupture (i.e., explosion) of the compressed gas oxygen cylinder, which can cause serious injury and/or death.

Affected products

OxyTOTE Style Valve Integrated Pressure Regulators 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • MNR-600
  • MNS-603
  • MTR-500
  • MTR-700
  • MTS-501
  • MTS-502
  • MTS-503
Companies
Manufacturer
Western / Scott Fetzer Co.
875 Bassett RD.,
Westlake
44145
Ohio
UNITED STATES