Recall Z-1828-2024— Andover Healthcare Inc.
Class II · Ongoing
Class II FDA medical device recall by Andover Healthcare Inc., initiated 2024-04-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S). Reason: A packaging seal gap could impact the sterility of the product..
- Recalling firm
- Andover Healthcare Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-02
- Firm location
- Salisbury, MA, United States
Product description
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Reason for recall
A packaging seal gap could impact the sterility of the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.