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Health product recall

Blom-Singer Adjustable Tracheostoma Valve II (2013-10-01)

Starting date:
October 1, 2013
Posting date:
October 31, 2013
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-36503

Recalled Products

Blom-Singer Adjustable Tracheostoma Valve II 

Reason

Product body component of the device is missing from the packaging. I.E.- Only the diaphragm valve/faceplate was packaged in the product packaging.

Affected products

Blom-Singer Adjustable Tracheostoma Valve II

Lot or serial number
  • 1057760
  • 1057919
  • 1059222
Model or catalog number
  • BE8025H
  • BE8025H-R3
Companies
Manufacturer

Helix Medical LLC,

also Trading As Inhealth Technologies,

1110 Mark Avenue

Carpinteria,

93013-2918

California

UNITED STATES