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FDA (Device enforcement)Recalled 2024-10-09class ii

MEDLINE INDUSTRIES, LP - Northfield: MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT

Hazard

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Details from the source

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: 58765 units Lot/code info: 85OHM 1) REF CDS820075V, UDI/DI 10193489846973 (each) 40193489846974 (case), Lot Numbers: 22GBP851; 2) REF CDS820075W, UDI/DI 10195327209797 (each) 40195327209798 (case), Lot Numbers: 22HBH009, 23ABB066, 22JBX603, 22JBX483, 23ABM869, 22LBB096, 23EBB528, 23FBH057; 3) REF CDS980774M, UDI/DI 10193489383713 (each) 40193489383714 (case), Lot Numbers: 22JBT027, 23ABE914, 22KBE813, 23ABR052, 23GBL705, 24ABK006, 23JBQ162, 23LBT739, 23LBT825; 4) REF CDS981322AB, UDI/DI 10193489929997 (each) 40193489929998 (case), Lot Numbers: 22DBS923, 23EBE751, 23BBE438, 23HBS136; 5) REF CDS981322AC, UDI/DI 10195327539481 (each) 40195327539482 (case), Lot Numbers: 23LBJ448, 23LBJ388, 24BBF433, 24DMH817; 6) REF CDS982398I, UDI/DI 10195327029449 (each) 40195327029440 (case), Lot Numbers: 22HBF545, 22IBC664, 22JBL415, 22LBH995, 23BBS835, 23LBA643, 23JBV944, 23IBE632, 23HBJ717, 23EBP485, 24ABO332, 23FBS672, 24BBK936, 24EBC031, 24DBD943, 24CBU322, 24GBD705; 7) REF CDS983450L, UDI/DI 10193489372335 (each) 40193489372336 (case), Lot Numbers: 23ABF826, 23BBG537, 22FBS278, 22KBE444, 23JBR792; 8) REF CDS983869J, UDI/DI 10195327457617 (each) 40195327457618 (case), Lot Numbers: 23HDA541; 9) REF CDS984261J, UDI/DI 10195327139629 (each) 40195327139620 (case), Lot Numbers: 22IBF149, 23EBG169, 23CBE760, 22LBJ360, 22KBS546, 22KBS547; 10) REF CDS984516L, UDI/DI 10195327338626 (each) 40195327338627 (case), Lot Numbers: 23FDA887, 23HDB446, 23LDA038, 23JDB032, 23IDB803, 24ADA525, 23LDB093; 11) REF CDS984516M, UDI/DI 1019

UPC codes

10193489846973, 40193489846974, 10195327209797, 40195327209798, 10193489383713, 40193489383714, 10193489929997, 40193489929998, 10195327539481, 40195327539482, 10195327029449, 40195327029440, 10193489372335, 40193489372336, 10195327457617, 40195327457618, 10195327139629, 40195327139620, 10195327338626, 40195327338627, 10195327629847, 40195327629848, 10195327156923, 40195327156924, 10195327584955, 40195327584956, 10193489645606, 40193489645607, 10195327091170, 40195327091171, 10195327412555, 40195327412556, 10195327398668, 40195327398669, 10195327339005, 40195327339006, 10195327059880, 40195327059881, 10193489961935, 40193489961936

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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