CoFlex NL Sterile Bandages Recalled for Packaging Seal Gaps
Andover Healthcare Inc. is recalling CoFlex NL sterile flexible cohesive bandages (model 5400S) due to packaging seal gaps that could compromise product sterility. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for sterile medical device with packaging integrity failure affecting product sterility. No illnesses or injuries have been reported, but this represents a risk-of-harm product where compromised packaging could result in non-sterile wound care application.
Plain-English summary
Andover Healthcare Inc. is recalling Sterile CoFlex NL Latex Free Flexible Cohesive Bandages (model 5400S, tan, 4-inch by 5-yard) due to packaging seal gaps that could compromise product sterility. The recall encompasses 108 cases containing 1,944 individual product packages.
A gap in the packaging seal could impact the sterile state of the product. No illnesses or injuries have been reported in connection with this recall.
The affected products were distributed nationwide to patients and healthcare facilities in California, Colorado, Georgia, Iowa, Indiana, Ohio, Minnesota, North Carolina, Pennsylvania, Texas, Virginia, and Washington.
Consumers and patients who have obtained this product should contact their healthcare provider or Andover Healthcare Inc. for information regarding replacement products or product returns.
The recalled product
- Product
- Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
- Manufacturer
- Andover Healthcare Inc.
- Category
- Medical Device — Wound Care
- Hazard
- packaging-defect
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number: 5400S
- UDI/DI: 10724004641072
- Batch 0031151359
- Lot 10009897233.
Distribution
Distributed nationwide across the United States.
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