Z-1828-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- April 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108 cases (1,944 individual product packages)
Product Description
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Reason for Recall
A packaging seal gap could impact the sterility of the product.
Distribution Pattern
US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
Code Information
Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.