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: 260 cases (520 units) Lot/code info: Item Number: DYNJ900415L, UDI/GTIN Case: 40195327029426, UDI/GTIN Each: 10195327029425, Lot Numbers: 22HBO658, 22JBV699
40195327029426, 10195327029425
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.