Health product recall

PNEUMOCLEAR Heated High-Flow Tube Set (2018-10-21)

Starting date:
October 21, 2018
Posting date:
November 28, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68404

Affected products

PNEUMOCLEAR Heated High-Flow Tube Set

Reason

It is possible that the packaging of the product can be damaged by the prongs on the tube set. This can lead to a potential impairment of the sterile barrier, and therefore the product being non-sterile.

Circumstances under which defectiveness was discovered: Customer complaint without adverse event.

Affected products

PNEUMOCLEAR Heated High-Flow Tube Set

Lot or serial number

various

Model or catalog number
  • 620050200
Companies
Manufacturer

W.O.M. WORLD OF MEDICINE GmbH

SALZUFER 8

BERLIN

10587

GERMANY