Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage recall: Sterility Concern
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Why was Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage recalled?
A packaging seal gap could impact the sterility of the product.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.
- Product
- Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
- Recalling firm
- Andover Healthcare Inc.
- Quantity
- 108 cases (1,944 individual product packages)
- Distribution
- US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
- Recall date
- May 22, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)