Device product
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Z-1828-2024
Product summary
- Event
- Event 94394
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 108 cases (1,944 individual product packages)
- Official record key
device-enforcement:Z-1828-2024
Official wording
Reason: A packaging seal gap could impact the sterility of the product.
Code information: Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.
Distribution pattern: US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
Derived failure modes
-
Unknown
A packaging seal gap could impact the sterility of the product.