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Health product recall

John Bunn Neb-U-Lite LX2 Nebulizer Compressor (2013-12-30)

Starting date:
December 30, 2013
Posting date:
February 11, 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-37887

Recalled Products

  1. John Bunn Neb-U-Lite LX2 Nebulizer Compressor 

Reason

GF Health Products Inc. (GFHP) has sold 5 John Bunn Neb-U-Lite LX2 nebulizer compressors in Canada without establishment license in violation of medical device regulations.

Affected products

A. John Bunn Neb-U-Lite LX2 Nebulizer Compressor

Lot or serial number

Serial numbers:

  • AMN165RP2617
  • AMN165RP2618
  • AMN165RP2621
  • AMN165RP5486
  • AMN165RP2620
Model or catalog number
  • JB0112-110
Companies
Manufacturer
Apex Medical Corp.
No. 9, Min Sheng St.
Tu-Cheng, New Taipei City
23679
TAIWAN, PROVINCE OF CHINA