Z-1476-2025 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
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
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
5400-020-108 UDI-DI: 07613327117226, Lot Numbers: 2023011317 2023021717 2023030932 2023040317 2023083017 2023102517 2024020517 2024080717; 5400-020-108ITL UDI-DI: 07613327117226, Lot Numbers: 2023012017 2023032817 2023042017 2023091117 2023111417 2023120517 2024011817 2023020732 2023041117 2023062017 2023092017 2023112017 2024010817 2024012417 2023031717 2023041417 2023082317 2023103117 2023112817 2024011217