Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Reason for recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Distribution: US Nationwide distribution. Quantity: 167074 units Lot/code info: 1) REF CDS760057J, UDI/DI 10195327008963 (each) 40195327008964 (case), Lot Numbers: 22FBX954, 22FBE976; 2) REF CDS760057K, UDI/DI 10195327274368 (each) 40195327274369 (case), Lot Numbers: 23ABU244, 22LBC409, 23GBN928, 23CBO552, 23EBA183, 23JBH987; 3) REF CDS760057L, UDI/DI 10195327533373 (each) 40195327533374 (case), Lot Numbers: 23KBL294; 4) REF CDS860015W, UDI/DI 10195327349509 (each) 40195327349500 (case), Lot Numbers: 23FBP597; 5) REF CDS860016P, UDI/DI 10193489848007 (each) 40193489848008 (case), Lot Numbers: 22FBQ637; 6) REF CDS860016Q, UDI/DI 10195327209599 (each) 40195327209590 (case), Lot Numbers: 23ABM653, 22KBA835, 22JBE511; 7) REF CDS860016R, UDI/DI 10195327349479 (each) 40195327349470 (case), Lot Numbers: 23GBD634; 8) REF CDS860062R, UDI/DI 10193489852073 (each) 40193489852074 (case), Lot Numbers: 22OBE627, 22OBA906; 9) REF CDS860062S, UDI/DI 10195327140632 (each) 40195327140633 (case), Lot Numbers: 22GBS435, 22GBO814, 23ABG350, 23DBG817, 23EBQ675; 10) REF CDS860194I, UDI/DI 10193489445152 (each) 40193489445153 (case), Lot Numbers: 22GBN008, 23BBR005, 22LBJ448, 22JBH327, 23GBL900, 23GBM243, 23DBE016, 22KBK702; 11) REF CDS920080R, UDI/DI 10195327079086 (each) 40195327079087 (case), Lot Numbers: 22GBZ014, 22GBD101; 12) REF CDS920080S, UDI/DI 10195327209605 (each) 40195327209606 (case), Lot Numbers: 23ABK590, 22JBO105; 13) REF CDS920080T, UDI/DI 10195327349486 (each) 40195327349487 (case), Lot Numbers: 23EBB523; 14) REF CDS930027U, UDI/DI 10193489288537 (each) 40193
10195327008963, 40195327008964, 10195327274368, 40195327274369, 10195327533373, 40195327533374, 10195327349509, 40195327349500, 10193489848007, 40193489848008, 10195327209599, 40195327209590, 10195327349479, 40195327349470, 10193489852073, 40193489852074, 10195327140632, 40195327140633, 10193489445152, 40193489445153, 10195327079086, 40195327079087, 10195327209605, 40195327209606, 10195327349486, 40195327349487, 10193489288537, 40193489288538, 10195327241759, 40195327241750, 10195327009649, 40195327009640, 10195327533342, 40195327533343, 10195327065423, 40195327065424, 10195327070649, 40195327070640, 10193489848342, 40193489848343
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.