Medline Industries, LP: MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D;

Hazard

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Details from the source

Reason for recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. Distribution: US Nationwide distribution. Quantity: 11032 kits Lot/code info: REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23JBR313; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23KBB240; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24DBA895; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24EBI651; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23FBP399; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23HBP624; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23IBE037; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23JBC747; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 23LBM204; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24ABL069; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24CBM113; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24FBE246; REF DYNJ02577D, UDI/DI: 10193489958003 (each) 40193489958004 (case), Lot Numbers: 23EDA073; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23GBP147; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBD395; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBP685; REF DYNJ0536924U, UDI/

UPC codes

10195327209797, 40195327209798, 10195327139629, 40195327139620, 10193489645606, 40193489645607, 10193489958003, 40193489958004, 10195327206246, 40195327206247, 10889942826582, 40889942826583, 10195327561871, 40195327561872, 10195327349431, 40195327349432, 10195327496609, 40195327496600, 10195327351373, 40195327351374, 10193489950946, 40193489950947, 10195327034757, 40195327034758, 10195327050528, 40195327050529, 10193489860832, 40193489860833, 10195327653354, 40195327653355, 10195327127381, 40195327127382, 10195327232603, 40195327232604, 10195327500054, 40195327500055, 10193489878257, 40193489878258, 10195327689773, 40195327689774

Source

Official record: FDA (Device enforcement) ↗

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