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

MEDLINE INDUSTRIES, LP - Northfield: MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D

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: 486 units Lot/code info: 1) REF CDS983465N, UDI/DI 10195327497309 (each) 40195327497300 (case), Lot Numbers: 24CDB460, 24BDA880, 23KDB948; 2)REF CDS983465N, UDI/DI 10195327699987 (each) 40195327699988 (case), Lot Numbers: 24EDB092, 24EDA519; 3) REF DYNJ63331D, UDI/DI UDI/DI 10195327270346 (each) 40195327270347 (case), Lot Numbers: 23LME440, 23HMI168, 23KMD370

UPC codes

10195327497309, 40195327497300, 10195327699987, 40195327699988, 10195327270346, 40195327270347

Source

Official record: FDA (Device enforcement)

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

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