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: 160 cases (480 units) Lot/code info: Item Number: DYNJ900416M, UDI/GTIN Case: 40195327031672, UDI/GTIN Each: 10195327031671, Lot Number: 22IBQ980
40195327031672, 10195327031671
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.