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: 36 cases (116 units) Lot/code info: a. WOUND CLOSURE TRAY, Item Number: DYNJ56703, Case UDI/GTIN: 40889942672418, Unit UDI/GTIN: 10889942672417, Lot Number: 22JBE355; b. WOUND PACK, Item Number: DYNJ80201A, Case UDI/GTIN: 40195327171538, Unit UDI/GTIN: 10195327171537, Lot Number: 22IBE619
40889942672418, 10889942672417, 40195327171538, 10195327171537
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.