Device product
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Z-2305-2026
Product summary
- Event
- Event 99044
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 800 units
- Official record key
device-enforcement:Z-2305-2026
Official wording
Reason: Sterile wound dressing, lacks sterility assurance
Code information: Lot: 63295141/UDI: None
Distribution pattern: US Nationwide distribution in the states of FL & NC.
Derived failure modes
-
Unknown
Sterile wound dressing, lacks sterility assurance