Medline Industries, LP: Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM

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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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: 74,085 units Lot/code info: 1) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125030001; 2) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125040001; 3) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBG562; 4) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBM956; 5) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 34124110001; 6) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 24LBR925; 7) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 25IDB410; 8) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 34124110001; 9) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23IBI440; 10) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23KBI254; 11) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABQ057; 12) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABR513; 13) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24GBL513; 14) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 25JDA853; 15) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 34124110001; 16) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23BBI300; 17) DYNJHWIRE115, UDI-

UPC codes

10195327188955, 40195327188956, 34125030001, 34125040001, 10195327301637, 40195327301638, 34124110001, 10195327302184, 40195327302185, 10195327306021, 40195327306022, 10195327302191, 40195327302192, 10195327301620, 40195327301621, 10195327306007, 40195327306008, 10195327301613, 40195327301614, 34125010001, 10198459475368, 40198459475369, 10198459475375, 40198459475376, 10195327305994, 40195327305995, 10195327302207, 40195327302208, 10195327301606, 40195327301607, 10195327302153, 40195327302154, 10195327302214, 40195327302215, 10195327308421, 40195327308422, 10195327308438, 40195327308439, 10195327308308, 40195327308309

Source

Official record: FDA (Device enforcement) ↗

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