Medical device manufacturer, Cordis, a Johnson & Johnson company, has issued a Field Safety Notice on Cordis S.M.A.R.T. ® CONTROL® Nitinol Stent System product.
Cordis has identified a potential sterility breach in the pouches of all unexpired lots (Lot Number 15525516 and below) of Cordis S.M.A.R.T. ® CONTROL® Nitinol Stent System product with the 65 Catalog Numbers listed below:
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Cordis revealed that the potential defect was detected during in-house testing on non-production product as part of a development project. Further investigation determined that conditions leading to a potential pathway through the seal exist in a small percentage of distributed products. Since the compromised seal is not readily apparent to the unaided eye and using of a non-sterile device may expose the patient to increased risk of infection, Cordis has decided to recall the product.
According to the local supplier, the affected product has been distributed in Hong Kong. For details, please refer to the attachment. If you are in possession of the products, please contact your supplier for necessary actions.
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