Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore ...
FDA Recall #Z-1480-2025 — Class II — February 25, 2025
Product Description
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
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.
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
182,344 total units
Distribution
US Nationwide distribution.
Code Information
5400-212-004S UDI-DI: 07613327500387, Lot Numbers: 2024011914; 5400-222-004S UDI-DI: 07613327500479, Lot Numbers: 2024021212 2024052813
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated