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: 216 units Lot/code info: Item Number: DYNJ908295, UDI/GTIN Case: 40195327029570, UDI/GTIN Each: 10195327029579, Lot Numbers: 22IBN449, 22JBQ931
40195327029570, 10195327029579
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.