DeRoyal Industries Inc: DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- DeRoyal Industries Inc
- Product
- DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
- Reason / hazard
- Sterile wound dressing, lacks sterility assurance
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of FL & NC.
- Recall initiated
- 2026-05-18
- Code info
- Lot: 63295141/UDI: None
- Product quantity
- 800 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Powell
- State
- TN
- Country
- United States
- Event id
- 99044
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