Device product
CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
Z-0898-2026
Product summary
- Event
- Event 97978
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 182,526 units
- Official record key
device-enforcement:Z-0898-2026
Official wording
Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Code information: UDI/DI 10888277702752 (each), 00888277702755 (box), 20888277702759 (case), ALL LOTS
Distribution pattern: US, Guam, Canada, United Arab Emirates
Derived failure modes
-
Sterility assurance
seals in the packaging which may compromise the sterility