Medline Industries, LP: MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF

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: 1315 kits Lot/code info: 1) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers: 23LMG063; 2) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers: 24ABG356, 24CBH117, 24DBJ347; 3) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers: 23JMC956, 23KMF585, 24AMB974; 4) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers: 23EBS176, 23GBF899, 23HBZ085; 5) REF DYNJ44882M, UDI/DI 10195327382803 (each) 40195327382804 (case), Lot Numbers: 23FDA522, 23GDB903; 6) REF DYNJ903870F, UDI/DI 10195327239268 (each) 40195327239269 (case), Lot Numbers: 23IBD913, 23IBD914, 23JBL889, 24ABE596, 24BBL042, 24CBH196, 24DBU825.

UPC codes

10195327418618, 40195327418619, 10193489445589, 40193489445580, 10195327356699, 40195327356690, 10195327105020, 40195327105021, 10195327382803, 40195327382804, 10195327239268, 40195327239269

Source

Official record: FDA (Device enforcement) ↗

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