Fiberscopes (2013-11-11)

Starting date:

November 11, 2013

Posting date:

December 4, 2013

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-37023

• 
  Reason
• 
  Affected products

Recalled products

1. Intubation Scope
2. Intubation Fiberscope
3. Ear, Nose And Throat Fiberscopes
4. Broncho Fiberscope

Reason

It has been determined that these endoscopes incorporate a lumen material that is only approved for use as an external surface material and not included in the Sterrad NX and 100NX labeling claims for use in flexible endoscope lumens. This could result in lower than expected levels of hydrogen peroxide within the lumen during the exposure phase of the sterilization cycle and compromise sterilization efficacy.

Affected products