Medline Industries, LP: Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2

Hazard

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Details from the source

Reason for recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. Distribution: US Nationwide distribution. Quantity: 17550 kits Lot/code info: Medline Kit SKU DT17360: UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025101090; Medline Kit SKU IVS1975A: UDI/DI each 10653160327936, UDI/DI case 00653160327939, Lot Number: 2025100890; Medline Kit SKU DT5565B: UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2025103190; Medline Kit SKU EBSI1172B: UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2025110590; Medline Kit SKU DT17360: UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025110790; Medline Kit SKU EBSI1171A: UDI/DI each 10888277781276, UDI/DI case 40888277781277, Lot Number: 2025111990; Medline Kit SKU EBSI1173A: UDI/DI each 10888277781320, UDI/DI case 40888277781321, Lot Number: 2025112490; Medline Kit SKU DM810: UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2025120990; Medline Kit SKU DM100: UDI/DI each 10653160280101, UDI/DI case 00653160280104, Lot Number: 2026010690; Medline Kit SKU DT5565B: UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2026011390; Medline Kit SKU EBSI1172B: UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2026011390; Medline Kit SKU DT7340: UDI/DI each 00653160091427, UDI/DI case 50653160091422, Lot Number: 2026021090; Medline Kit SKU DM660: UDI/DI each 10653160290667, UDI/DI case 00653160290660, Lot Number: 2026020690; Medline Kit SKU DM810: UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2026020990; Medline Kit SKU EBSI1171A: UDI

UPC codes

10653160264965, 00653160264968, 10653160327936, 00653160327939, 00653160126938, 10653160126935, 10193489195453, 20193489195450, 10888277781276, 40888277781277, 10888277781320, 40888277781321, 10653160304739, 00653160304732, 10653160280101, 00653160280104, 00653160091427, 50653160091422, 10653160290667, 00653160290660, 10653160355724, 00653160355727

Source

Official record: FDA (Device enforcement) ↗

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