TEM Insufflation Tubing (2020-06-05)

Starting date:

June 5, 2020

Posting date:

June 26, 2020

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-73429

Last updated: 2020-06-29

• 
  Reason
• 
  Affected products

Affected Products

TEM Insufflation Tubing

Reason

The TEM tube set consists of several tubes. With the pump hose from this set, it was found that the hose material used does not meet the dimensional specifications. The hose set is used in conjunction with a hose pump / roller pump. The way it works is based on an alternation of tension and relaxation of the flexible hose, which is pinched by rollers that rotate on a rotor. This draws medium into the hose and ejects it again. Due to the dimensional deviation, the the pump can no longer be guaranteed to function as specified.

Affected products