Warning
Medline Industries Recalls Medline and Centurion medical convenience kits
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2045-2026Medical Device
Medline Industries Recalls Medline and Centurion medical convenience kits
Medline Industries, LP · Class II — Moderate Risk
Product Description
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B; 4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B; 5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A; 6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A; 7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810; 8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100; 9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340; 10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660; 11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A.
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database