Medline Industries, LP: Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Numb

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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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: 160883 units Lot/code info: 1) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 25ALA420; 2) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 25CLA774; 3) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 24LLA038; 4) DYNDH2104, UDI-DI: 10198459273964(each), 40198459273965(case), Lot Number: 25DBR609; 5) DYNJT2164M, UDI-DI: 10198459003165(each), 40198459003166(case), Lot Number: 24JBT885; 6) DYNJT3078, UDI-DI: 10198459305146(each), 40198459305147(case), Lot Number: 25DBN722; 7) DYNJT4190, UDI-DI: 10198459428234(each), 40198459428235(case), Lot Number: 25HBA387; 8) DYNJT5717, UDI-DI: 10198459496684(each), 40198459496685(case), Lot Number: 26ALA778; 9) DYNJ0381139R, UDI-DI: 10198459276019(each), 40198459276010(case), Lot Number: 25JLA029; 10) DYNJ04529L, UDI-DI: 10198459391460(each), 40198459391461(case), Lot Number: 25JLA312; 11) DYNJ07955L, UDI-DI: 10889942628896(each), 40889942628897(case), Lot Number: 24HBM316; 12) DYNJ07955L, UDI-DI: 10889942628896(each), 40889942628897(case), Lot Number: 23HBX895; 13) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 23DBP876; 14) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 23FBG933; 15) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24GBE563; 16) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24HBT787; 17) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot

UPC codes

10889942778546, 40889942778547, 10198459273964, 40198459273965, 10198459003165, 40198459003166, 10198459305146, 40198459305147, 10198459428234, 40198459428235, 10198459496684, 40198459496685, 10198459276019, 40198459276010, 10198459391460, 40198459391461, 10889942628896, 40889942628897, 10195327295639, 40195327295630, 10889942297122, 40889942297123, 10198459091476, 40198459091477, 10198459132636, 40198459132637, 10195327539160, 40195327539161, 10193489440171, 40193489440172, 10193489841428, 40193489841429, 10195327630614, 40195327630615, 10193489979398, 40193489979399, 10195327650117, 40195327650118, 10889942341764, 40889942341765

Source

Official record: FDA (Device enforcement) ↗

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