FDAFDA · Food and drugs·Recall number Z-1828-2024
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Published May 22, 2024 · Recall initiated: April 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A packaging seal gap could impact the sterility of the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Andover Healthcare Inc.
- Distributor
- US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
- Lot
- Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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