da Vinci S/Si Harmonic ACE Insert (2019-01-14)

Starting date:

January 14, 2019

Posting date:

January 31, 2019

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-68964

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  Reason
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  Affected products

Affected Products

da Vinci S/Si Harmonic ACE Insert

Reason

Si Harmonic ACE Insert pouches were shown to have a potential breach in sterility during transit. The pin holes or small openings less than a few millimeters may lead to a breach in sterility of the Harmonic ACE Insert.

Affected products