Product received nationwide distribution to approx. 38 direct consignees. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians who received the recalled product. There is no known Canadian distribution.
Description du dispositif
BiodivYsio¿ SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; || Catalog #: B3225-10, Lot #: 010586G; || Catalog #: B3225-10, Lot #: 030176G; || Catalog #: B3225-15, Lot #: 010626G; || Catalog #: B3225-18, Lot #: 020246G.