Medline Industries, LP: Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUR

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: 28550 kits Lot/code info: Medline Kit SKU IV8310E: UDI/DI each 10653160293798, UDI/DI case 00653160293791, Lot Number: 2025102390; Medline Kit SKU IVS1700: UDI/DI each 10653160259213, UDI/DI case 00653160259216, Lot Number: 2025102390; Medline Kit SKU IV8675: UDI/DI each 10653160319160, UDI/DI case 00653160319163, Lot Number: 2025110790; Medline Kit SKU IVSSTK12: UDI/DI each 10653160322511, UDI/DI case 00653160322514, Lot Number: 2025111890; Medline Kit SKU IV6940: UDI/DI each 00653160194210, UDI/DI case 10653160194217, Lot Number: 2025112690; Medline Kit SKU IV8775: UDI/DI each 10888277732537, UDI/DI case 20888277732534, Lot Number: 2025120190; Medline Kit SKU IVSSTK12: UDI/DI each 10653160322511, UDI/DI case 00653160322514, Lot Number: 2025122690; Medline Kit SKU IVS1700: UDI/DI each 10653160259213, UDI/DI case 00653160259216, Lot Number: 2026010590; Medline Kit SKU IV8675: UDI/DI each 10653160319160, UDI/DI case 00653160319163, Lot Number: 2026010990; Medline Kit SKU IV8310E: UDI/DI each 10653160293798, UDI/DI case 00653160293791, Lot Number: 2026011990; Medline Kit SKU IV6940: UDI/DI each 00653160194210, UDI/DI case 10653160194217, Lot Number: 2026012990.

UPC codes

10653160293798, 00653160293791, 10653160259213, 00653160259216, 10653160319160, 00653160319163, 10653160322511, 00653160322514, 00653160194210, 10653160194217, 10888277732537, 20888277732534

Source

Official record: FDA (Device enforcement) ↗

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