Medical device manufacturer, California Medical Laboratories, Inc. has initiated a field safety corrective action concerning the Standard Rigid Tip Suction Wand (Item no.: SU-12202, Lot no.: S111480 and S112462).
Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. This would likely be identified during, or prior to, the procedure. If the issue goes unnoticed there is the possibility of risk to the patient should the clinician not remove the detached component and subsequently close the surgical site.
The manufacturer is notifying the affected users not to use the affected products and to return any unused product and order replacements.
According to ConMed Limited, the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 7 November 2012