Medline Industries, LP: Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT

Hazard

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Details from the source

Reason for recall: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Distribution: US Nationwide distribution. Quantity: 2609 units Lot/code info: 1) DYNJ32841F, UDI-DI: 10195327037796(each), 40195327037797(case), Lot Number: 24CBF407; 2) DYNJ46069D, UDI-DI: 10193489493184(each), 40193489493185(case), Lot Number: 24KBG704; 3) DYNJ51935A, UDI-DI: 10889942735549(each), 40889942735540(case), Lot Number: 24BME364; 4) DYNJ68902A, UDI-DI: 10193489870411(each), 40193489870412(case), Lot Number: 24BMC999; 5) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 22KBJ690; 6) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23BBD696; 7) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23DBG588; 8) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23FBD221; 9) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23GBN050; 10) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23IBB710; 11) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23LBM277; 12) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24CBN011; 13) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24DBK248; 14) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24GBC694; 15) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24HBX136; 16) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24IBR538; 17) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), L

UPC codes

10195327037796, 40195327037797, 10193489493184, 40193489493185, 10889942735549, 40889942735540, 10193489870411, 40193489870412, 10195327273705, 40195327273706, 10198459220227, 40198459220228, 10195327349882, 40195327349883

Source

Official record: FDA (Device enforcement) ↗

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