Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Reason for recall: Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. Distribution: US Nationwide distribution in the states of AR, MD, WA, WI. Quantity: 12 cases (24 units) Lot/code info: Item Number: DYNJ900413P, UDI/GTIN Case: 40195327031665, UDI/GTIN Each: 40195327031665, Lot Number: 22JDB689
40195327031665
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.