FDA-Device2025-04-09Class II
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
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
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1477-2025Don't want to check this manually?
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