RecallRadar

FDA Device recall Z-2043-2026

Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion),…

On 2026-05-06 the FDA classified a Class II recall of Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion),… by Medline Industries, citing 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 We….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2043-2026
ClassificationClass II
Statusongoing
Initiated2026-03-16
Published2026-05-06
Last updated2026-09-13 11:58 UTC
CompanyMedline Industries
DistributionUS

Product

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 SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV8675; 4. NEONATAL IV SECUREMENT KIT W/SHIELD(Centurion), Medline Kit SKU IVSSTK12; 5. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 6. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775; 7. NEONATAL IV SECUREMENT KIT W/SHIELD, Medline Kit SKU IVSSTK12; 8. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 9. IV START KIT, Medline Kit SKU IV8675; 10. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 11. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 12. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775.

Reason

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.

Identifiers

code_info
Medline Kit SKU IV8310E: UDI/DI each 10653160293798, UDI/DI case 00653160293791, Lot Number: 2025102390; Medline Kit…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 1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2043-2026%22

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