FDA Enforcement
Class II
Ongoing
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Recall: Z-1480-2025
·
Reported April 9, 2025
Enforcement
- Recall Number
- Z-1480-2025
- Event ID
- 96393
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 9, 2025
- Initiation Date
- February 25, 2025
- Classification Date
- March 28, 2025
- Address
- 1941 Stryker Way, Portage, MI, 49002-9711, United States
Description
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
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 Info
5400-212-004S UDI-DI: 07613327500387, Lot Numbers: 2024011914; 5400-222-004S UDI-DI: 07613327500479, Lot Numbers: 2024021212 2024052813
Distribution
US Nationwide distribution.
Quantity
182,344 total units