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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
Related recalls
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See all →- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect
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Similar recalls
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects
FDA (Devices) · 2019-10-30
- ModerateAndover Healthcare Recalls Sterile Co-Flex Med Wound Dressings Due to Packaging Seal Defects
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex Med Wound Dressings
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- HighAdhesive bandages recalled over open package seals that may compromise sterility
FDA (Devices) · 2025-12-17