Kii Optical Access System (2021-05-18)

Starting date:

May 18, 2021

Posting date:

June 10, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-75781

Last updated:
2021-06-10

• 
  Reason
• 
  Affected products

Affected Products 

Kii Optical Access System

Reason

Applied Medical has identified that some boxes of CFR03 Kii Optical Access System contain an incorrect IFU. The boxes with the incorrect IFU contain the Kii Fios First Entry IFU, rather than the correct Kii Optical Access System IFU. Both systems have the same indications.

Affected products