Device product
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Z-1482-2025
Product summary
- Event
- Event 96393
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 182,344 total units
- Official record key
device-enforcement:Z-1482-2025
Official wording
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Code information: 5400-222-208S UDI-DI: 07613327500486, Lot Numbers: 2024020221 2024051720 2024082321
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.