Drug recall
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
FDA recall event 94394 · Class II · Andover Healthcare Inc.
Key facts
| Event ID | 94394 |
|---|---|
| Recall numbers | Z-1828-2024 |
| Recalling firm | Andover Healthcare Inc. |
| Product type | Devices |
| Products | Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A packaging seal gap could impact the sterility of the product. |
| Initiation date | Apr 2, 2024 |
| Report date | May 22, 2024 |
| City | Salisbury |
| State | MA |
| Country | United States |
| FEI number | 1220799 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: