Medline Industries, LP: Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSI

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: 40845 kits Lot/code info: Medline Kit SKU UROT1044: UDI/DI each 10889942873890, UDI/DI case 40889942873891, Lot Number: 26BBC230; Medline Kit SKU IV8770: UDI/DI each 10653160382638, UDI/DI case 00653160382631, Lot Number: 2025101090; Medline Kit SKU DYNDV2520: UDI/DI each 10653160384045, UDI/DI case 00653160384048, Lot Number: 2025112090; Medline Kit SKU ART255: UDI/DI each 10653160367598, UDI/DI case 00653160367591, Lot Number: 2025111890; Medline Kit SKU DYNDC2969: UDI/DI each 10653160376071, UDI/DI case 00653160376074, Lot Number: 2025120190; Medline Kit SKU DYNDV2520: UDI/DI each 10653160384045, UDI/DI case 00653160384048, Lot Number: 2026010290; Medline Kit SKU IV8770: UDI/DI each 10653160382638, UDI/DI case 00653160382631, Lot Number: 2026010790; Medline Kit SKU ART255: UDI/DI each 10653160367598, UDI/DI case 00653160367591, Lot Number: 2026012090; Medline Kit SKU DYNDC2969: UDI/DI each 10653160376071, UDI/DI case 00653160376074, Lot Number: 2026012390; Medline Kit SKU EBSI1364A: UDI/DI each 10653160363163, UDI/DI case 00653160363166, Lot Number: 2026010690.

UPC codes

10889942873890, 40889942873891, 10653160382638, 00653160382631, 10653160384045, 00653160384048, 10653160367598, 00653160367591, 10653160376071, 00653160376074, 10653160363163, 00653160363166

Source

Official record: FDA (Device enforcement) ↗

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