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: 48 cases (96 units) Lot/code info: Item Number: DYNJ0185290G, Case UDI/GTIN: 40193489378055, Unit UDI/GTIN: 10193489378054, Lot Number: 22HME772;
40193489378055, 10193489378054
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.