Stryker Corporation: Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL

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.

Details from the source

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. Distribution: US Nationwide distribution. Quantity: 182,344 total units Lot/code info: 5400-010-004 UDI-DI: 07613154340798, Lot Numbers: 2022101814 2023021412 2023082413 2024022915 2022111414 2023051712 2023090114 2022102413 2023022133 2023090613 2024031915 2023011013 2023052415 2023110315 2022111413 2023050913 2023091912 2024032215 2023011913 2023061615 2023112314 2023011613 2023051213 2023103115 2024040214 2023020113 2023062132 2024011912 2023012413 2023071713 2023110812 2024052915 2023020333 2023062615 2024020813 2023012713 2023080812 2023112018 2024062412 2023020612 2023062915 2024080117 2023020912 2023081112 2024011613 2024080912 2023050414 2023070433 2024082216; 5400-010-004ITL UDI-DI: 07613327359435, Lot Numbers: 2022111414 2023051712 2023090114 2023011013 2023052415 2023110315 2023011913 2023061615 2023112314 2023020113 2023062132 2024011912 2023020333 2023062615 2024020813 2023020612 2023062915 2024080117 2023050414 2023070433 2024082216

UPC codes

07613154340798, 07613327359435

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.