During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Reason for recall: During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed). Distribution: U.S.: New York, Florida, Maryland, North Carolina, Virginia, Georgia, Rhode Island, New Jersey, Pennsylvania, Illinois, South Carolina, Maine, and Massachusetts. O.U.S.: N/A Quantity: 56,080 units Lot/code info: Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865
00382903835164
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.