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Otoclear Ear Irrigation System (2014-02-21)
- Starting date:
- February 21, 2014
- Posting date:
- April 4, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38675
Recalled products
- Otoclear Ear Irrigation
- Otoclear Ear Irrigation System
Reason
The reason for the recall was a stop sale of the devices for a classification error. There is no hazard for the patient or user of the product.
Affected products
A. Otoclear Ear Irrigation System
Lot or serial number
- 7245
Model or catalog number
- 7245
Companies
- Manufacturer
-
Bionix Development Corporation
5154 Enterprise Blvd.
Toledo
43612
Ohio
UNITED STATES
B. Otoclear Ear Irrigation System
Lot or serial number
- 7280
Model or catalog number
- 7280
Companies
- Manufacturer
-
Bionix Development Corporation
5154 Enterprise Blvd.
Toledo
43612
Ohio
UNITED STATES