Z-1482-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2025
- Initiation Date
- February 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 182,344 total units
Product Description
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
5400-222-208S UDI-DI: 07613327500486, Lot Numbers: 2024020221 2024051720 2024082321