Stryker Corporation: Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL

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: 5400-020-008 UDI-DI: 07613154340828, Lot Numbers:2022101214 2023011115 2023021612 2023061932 2023101632 2024011532 2024051512 2022101314 2023011212 2023031312 2023062612 2023110232 2024021914 2024072631 2022101414 2023011314 2023031414 2023062812 2023113034 2024022731 2024081312 2022101914 2023011615 2023042413 2023072433 2023120732 2024030431 2024082614 2023010912 2023011814 2023050212 2023091112 2023121532 2024031932 2024082812 2022101214 2023011115 2023021612 2023061932 2023101632 2024011532 2024051512 2023011015 2023021313 2023051014 2023091212 2023121832 2024050814 ; 5400-020-008ITL UDI-DI: 07613327359428, Lot Numbers: 2022101912 2023030914 2023070715 2023073132 2023090512 2023101012 2023110832 2023120612 2022102614 2023031015 2023070712 2023080132 2023090712 2023101014 2023111314 2023120633 2022110714 2023032932 2023071132 2023080232 2023090814 2023101133 2023110932 2023120714 2022110814 2023042614 2023071133 2023080233 2023091214 2023101114 2023111332 2023120712 2022110914 2023050113 2023071134 2023080332 2023091314 2023101314 2023111333 2023120814 2022111014 2023050312 2023071135 2023080732 2023091416 2023101313 2023111514 2023120812 2022111114 2023050412 2023071232 2023080733 2023091514 2023101615 2023111632 2023121232 2022111715 2023061414 2023071233 2023080932 2023091815 2023101612 2023112132 2023121233 2022111814 2023061933 2023071432 2023080833 2023091916 2023101832 2023112012 2023121333 2022113014 2023061913 2023071433 2023081132 2023092014 2023101814 2023112215

UPC codes

07613154340828, 07613327359428

Source

Official record: FDA (Device enforcement) ↗

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