Medline Industries, LP: Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYR

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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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: 38014 units Lot/code info: 1) DYKB1038, UDI-DI: 10193489502428(each), 40193489502429(case), Lot Number: 22GBJ869; 2) DYNDA3188, UDI-DI: 10198459303579(each), 40198459303570(case), Lot Number: 25DBF256; 3) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA998; 4) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA723; 5) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBH579; 6) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBS213; 7) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21DBS220; 8) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21HBK178; 9) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21IBV194; 10) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBJ063; 11) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBM583; 12) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABG678; 13) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABZ724; 14) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22DBL342; 15) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22IBS978; 16) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22JBV884; 17) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case),

UPC codes

10193489502428, 40193489502429, 10198459303579, 40198459303570, 10198459065453, 40198459065454, 10884389882054, 40884389882055, 10198459347054, 40198459347055, 10198459492129, 40198459492120, 10193489548204, 40193489548205, 10198459023750, 40198459023751, 10198459015656, 40198459015657, 10195327609931, 40195327609932, 10198459223679, 40198459223670, 10193489768282, 40193489768283, 10198459079634, 40198459079635, 10889942811663, 40889942811664, 10198459087318, 40198459087319, 10889942491377, 40889942491378, 10198459368318, 40198459368319, 10195327543624, 40195327543625, 10195327592554, 40195327592555, 10195327556518, 40195327556519

Source

Official record: FDA (Device enforcement) ↗

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