Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Reason for recall: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates. Quantity: 12 cases (60 units) Lot/code info: a. PAIN SERVICE PACK-LF, Item Number: DYNJ0101290D, Case UDI/GTIN: 40193489345552, Unit UDI/GTIN: 10193489345551, Lot Number: 22HDC372; b. LOCAL BASIC, Item Number: DYNJ34418L, Case UDI/GTIN: 40193489969277, Unit UDI/GTIN: 10193489969276, Lot Number: 22HBQ831, 22HBO949;
40193489345552, 10193489345551, 40193489969277, 10193489969276
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.