F.A.S.T. First Aid & Survival Technologies MDEL # 3951, Company ID: 130817
Medical Device Establishment Licencing (MDEL) was implemented to allow users to be made aware of who is importing and/or selling medical devices in Canada.
It requires establishment license holders to provide to Health Canada the assurance that they have met the regulatory requirements and have documented procedures in place, where applicable, related to distribution records, complaint handling, storage, delivery, installation, and servicing, with respect to the medical devices they sell.
Any Canadian company selling registered medical devices, Class 1 through 4, must hold a valid MDEL.
Date: March 15, 2017
Covidien Curity Eye Pad
Reason for recall: This voluntary recall is being conducted due to the potential for the sterile packaging to be compromised on specific item codes and production lots.