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Recall Observatory FDA recall evidence

Device product

Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S

Z-1480-2025

February 25, 2025

Class II

Product summary

Firm
Stryker Corporation
Event
Event 96393
Status
Ongoing
Classification
Class II
Quantity
182,344 total units
Official record key
device-enforcement:Z-1480-2025

Official wording

Reason: 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.

Code information: 5400-212-004S UDI-DI: 07613327500387, Lot Numbers: 2024011914; 5400-222-004S UDI-DI: 07613327500479, Lot Numbers: 2024021212 2024052813

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.