DISPOSABLE BIPOLAR ABLATOR, ASPIRATING & NON-ASPIRATING (2021-02-01)

Starting date:

February 1, 2021

Posting date:

March 11, 2021

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-75093

Last updated:
2021-03-11

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  Reason
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  Affected products

Affected Products 

A. DISPOSABLE BIPOLAR ABLATOR, ASPIRATING

B. DISPOSABLE BIPOLAR ABLATOR, NON-ASPIRATING

Reason

Package integrity failure leading to potential breach of the sterile barrier and potential contamination of the sterile product inside packaging. There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration. Issue was discovered after worst case transportation / handling / shipping/extreme temperature conditions showed package integrity failure in 10.5% of samples tested.

Affected products