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: 26 cases (104 units) Lot/code info: a. UNIVERSAL PLASTIC, Item Number: DYNJ04047C, Case UDI/GTIN: 40888277855060, Unit UDI/GTIN: 10888277855069, Lot Number: 22IBH860,22IBJ054; b. KNEE ARTHROSCOPY PACK, Item Number: DYNJ24784C, Case UDI/GTIN: 40889942732587, Unit UDI/GTIN: 10889942732586, Lot Number: 22JBM001;
40888277855060, 10888277855069, 40889942732587, 10889942732586
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.