Device product
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
Z-2044-2026
Product summary
- Event
- Event 98692
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 432 kits
- Official record key
device-enforcement:Z-2044-2026
Official wording
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.
Code information: UDI/DI each 10653160280644, UDI/DI case 00653160280647. Lot Numbers: 2025102090, 2026010990.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.