Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte ...
FDA Recall #Z-1478-2025 — Class II — February 25, 2025
Product Description
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
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
5400-030-004 UDI-DI: 07613154340835, Lot Numbers: 2024052333 2023012514 2023050514 2023080912 2024020214; 5400-030-004ITL UDI-DI: 07613327359442, Lot Numbers: 2023071933 2023102714 2024012314
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated