FDA Enforcement
Class II
Ongoing
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Recall: Z-1828-2024
·
Reported May 22, 2024
Enforcement
- Recall Number
- Z-1828-2024
- Event ID
- 94394
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Andover Healthcare Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 22, 2024
- Initiation Date
- April 2, 2024
- Classification Date
- May 15, 2024
- Address
- 9 Fanaras Dr, N/A, Salisbury, MA, 01952-1444, United States
Description
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Reason
A packaging seal gap could impact the sterility of the product.
Code Info
Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.
Distribution
US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
Quantity
108 cases (1,944 individual product packages)