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: 20 cases (72 units) Lot/code info: a. ENDOSCOPY-LF, Item Number: DYNJ22890M, Case UDI/GTIN: 40193489766487, Unit UDI/GTIN: 10193489766486, Lot Number: 22JBM081; b. SEPTO/ENDO, Item Number: DYNJ902831D, Case UDI/GTIN: 40193489231671, Unit UDI/GTIN: 10193489231670, Lot Number: 22JBP701;
40193489766487, 10193489766486, 40193489231671, 10193489231670
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.