FDA-Device2025-04-09Class II
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Stryker Corporation
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
182,344 total units
Manufactured in
1941 Stryker Way, Portage, MI, United States
Products
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1471-2025Don't want to check this manually?
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