FDA Enforcement
Class II
Ongoing
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
Recall: Z-2044-2026
·
Reported May 6, 2026
Enforcement
- Recall Number
- Z-2044-2026
- Event ID
- 98692
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 6, 2026
- Initiation Date
- March 16, 2026
- Classification Date
- April 30, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
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 Info
UDI/DI each 10653160280644, UDI/DI case 00653160280647. Lot Numbers: 2025102090, 2026010990.
Distribution
US Nationwide distribution.
Quantity
432 kits