Device product
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
Z-2040-2026
Product summary
- Event
- Event 98692
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4050 kits
- Official record key
device-enforcement:Z-2040-2026
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: Medline Kit SKU DYNDH1520: UDI/DI each 10193489197679, UDI/DI case 20193489197676, Lot Number : 2025101301; Medline Kit SKU DYNDH1520: UDI/DI each 10193489197679, UDI/DI case 20193489197676, Lot Number : 2025113001; Medline Kit SKU EBSI1317: UDI/DI each 10193489195804, UDI/DI case 20193489195801, Lot Number : 2025120390; Medline Kit SKU EBSI1317: UDI/DI each 10193489195804, UDI/DI case 20193489195801, Lot Number : 2026022390.
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.